VersaCross Connect LAAC Access Solution VXAK0007 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00685447012597), received between Jan 3, 2023 and Jun 23, 2026 — classified as 3 deaths, 49 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (38 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• DeathJun 23, 2026Off-Label Use; Device Sensing Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. DURING A STROKE PREVENTION WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION RF WIRE AND DILATOR WERE SELECTED FOR TRANSSEPTAL ACCESS. DURING POSITIONING PRIOR TO TRANSSEPTAL PUNCTURE (TSP), THE PHYSICIAN POSITIONED TOO LOW ON THE SEPTUM AND WAS ADVISED BY THE CLINICAL SPECIALIST TO RETURN TO THE SUPERIOR VENA CAVA AND REATTEMPT POSITIONING USING THE WIRE; HOWEVER, THIS RECOMMENDATION WAS NOT FOLLOWED. THE ECHO CARDIOLOGIST ALSO CAUTIONED THAT THE NEEDLE ORIENTATION APPEARED DIRECTED TOWARD THE AORTA. TSP WAS SUBSEQUENTLY PERFORMED. AFTER PUNCTURE, AN ATTEMPT WAS MADE TO ADVANCE THE VERSACROSS WIRE INTO THE LEFT UPPER PULMONARY VEIN (LUPV), BUT VISUALIZATION WAS LOST ON ECHOCARDIOGRAPHY. ALTHOUGH THE WIRE APPEARED TO BE IN POSITION, THE PHYSICIAN REMOVED THE VERSACROSS WIRE AND REPLACED IT WITH A STANDARD 0.035-INCH J-TIP WIRE AGAINST THE CLINICAL SPECIALIST'S ADVICE. A PRE-EXISTING PERICARDIAL EFFUSION OF APPROXIMATELY 10 MM WAS PRESENT BEFORE THE PROCEDURE AND FOLLOWING TSP THE EFFUSION BEGAN TO ENLARGE TO MORE THAN TWICE ITS ORIGINAL SIZE. AS THE EFFUSION INCREASED, HEMODYNAMIC COMPROMISE DE

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25597926 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A THROMBOSIS OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE IMPLANTING PHYSICIAN REQUESTED A HALF DOSE HEPARIN TO BE GIVEN TO THE PATIENT. THE TRANSSEPTAL WAS COMPLETED BY THE PHYSICIAN AND REQUESTED THE OTHER HALF DOSE OF HEPARIN TO BE GIVEN. IT WAS AT THIS TIME THAT ANESTHESIA STATED THEY HAD NOT GIVEN ANY AND WILL GIVE THE FULL DOSE. A THROMBUS WAS NOTED BY THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PHYSICIAN ON THE END OF THE TRUSTEER/VERSACROSS CONNECT SHEATH/DILATOR. THE PHYSICIAN SUCTIONED THE THROMBUS AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS SUCCESSFULLY COMPETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT WOKE UP NEUROLOGICALLY INTACT AND IS EXPECTED TO BE DISCHARGED HOME THE NEXT DAY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PHYSICIAN ATTRIBUTES THE THROMBUS FORMATION DUE TO THE DELAY IN HEPARIN BEING GIVEN AND A NON-THERAPEUTIC ACTIVATED CLOTTING TIME (ACT) ONCE TO THE LEFT SIDE OF THE HEART. THERE WAS NO DIFFICULTY NOTED WITH TRANSSEPTAL PUNCTURE OR ANY MALFUNCTIONS NOTED WITH VERSACROSS DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20507260 ↗
• MalfunctionOct 8, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. WHEN THE PHYSICIAN TRIED TO BUZZ ACROSS SEVERAL TIMES, THE VERSACROSS RF WIRE WOULD NOT CROSS THIN SEPTAL TISSUE. THE RF SETTING WAS INCREASED HOWEVER THE RF WIRE STILL COULD NOT CROSS SEPTUM. THERE WERE NO ERROR CODES NOTED, AND THE RF TONE WAS HEARD EACH TIME ATTEMPTED TO CROSS (6-7). ALSO, BOTH RF WIRE AND CABLE CONNECTER WERE REPLACED. HENCE, TO RESOLVE THE ISSUE, A NEW KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (MISPLACED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401139 ↗
• InjuryOct 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. DURING THE PROCEDURE, THE VERSACROSS CONNECT SYSTEM WAS USED IN COMBINATION WITH THE TRUSTEER SHEATH. GROIN ACCESS TOOK PLACE SUCCESSFULLY, 8000 UNITS OF HEPARIN WAS GIVEN TO PATIENT, AND TRANSSEPTAL ACCESS WAS ACHIEVED AT A LOW/POSTERIOR POINT, WITH NO DIFFICULTY NOTED. A FEW MINUTES AFTER TRANSSEPTAL, WHEN THE VERSACROSS SYSTEM AND TRUSTEER WERE IN THE LEFT ATRIUM (LA), THE ECHOCARDIOLOGIST NOTICED A SMALL PE. A FEW MANIPULATIONS WERE PERFORMED IN ORDER TO PUSH THE VERSACROSS WIRE INTO THE LEFT ATRIAL APPENDAGE (LAA) WITHOUT SUCCESS. IT WAS AN ANEURYSMAL SEPTUM AND TENTING OF THE ATRIAL SEPTUM WAS NOTED. SHORTLY AFTER, THEY IDENTIFIED THAT THE PE WAS LARGER (POSTERIOR). ONCE CONFIRMED, THE PERICARDIOCENTESIS WAS THEN PERFORMED, AND THE PATIENT REMAINED STABLE THROUGHOUT. LATER ON, THE PE WAS MEASURED TO BE 2CM. CELL SAVER WAS USED AND THE DRAINAGE WAS FINISHED (160 CC IN TOTAL). FOLLOWING THE INTERVENTION, THE SITUATION WAS UNDER CONTROL AND THE LAA CLOSURE WAS COMPLETED SUCCESSFULLY USING THE ORIG

  Patient problems: Pericardial Effusion

  MAUDE report 20354155 ↗
• InjuryOct 2, 2024Positioning Problem; Positioning Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. DURING THE PROCEDURE, THE VERSACROSS CONNECT SYSTEM WAS USED IN COMBINATION WITH THE TRUSTEER SHEATH. GROIN ACCESS TOOK PLACE SUCCESSFULLY, 8000 UNITS OF HEPARIN WAS GIVEN TO PATIENT, AND TRANSSEPTAL ACCESS WAS ACHIEVED AT A LOW/POSTERIOR POINT, WITH NO DIFFICULTY NOTED. A FEW MINUTES AFTER TRANSSEPTAL, WHEN THE VERSACROSS SYSTEM AND TRUSTEER WERE IN THE LEFT ATRIUM (LA), THE ECHOCARDIOLOGIST NOTICED A SMALL PE. A FEW MANIPULATIONS WERE PERFORMED IN ORDER TO PUSH THE VERSACROSS WIRE INTO THE LEFT ATRIAL APPENDAGE (LAA) WITHOUT SUCCESS. IT WAS AN ANEURYSMAL SEPTUM AND TENTING OF THE ATRIAL SEPTUM WAS NOTED. SHORTLY AFTER, THEY IDENTIFIED THAT THE PE WAS LARGER (POSTERIOR). ONCE CONFIRMED, THE PERICARDIOCENTESIS WAS THEN PERFORMED, AND THE PATIENT REMAINED STABLE THROUGHOUT. LATER ON, THE PE WAS MEASURED TO BE 2CM. CELL SAVER WAS USED AND THE DRAINAGE WAS FINISHED (160 CC IN TOTAL). FOLLOWING THE INTERVENTION, THE SITUATION WAS UNDER CONTROL AND THE LAA CLOSURE WAS COMPLETED SUCCESSFULLY USING THE ORIG

  Patient problems: Pericardial Effusion

  MAUDE report 20354096 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CARDIAC ARREST OCCURRED. THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. THE PHYSICIAN GOT RIGHT FEMORAL ACCESS AND CROSSED THE SEPTUM WITH THE VERSACROSS SYSTEM. THE PATIENT'S OXYGEN SATURATION BEGAN TO DROP ROUGHLY THIRTY SECONDS AFTER CROSSING THE SEPTUM, THE HEART RATE DROPPED, AND PULSE WAS WEAK. THE ECHOCARDIOGRAM LOOKED FOR EFFUSION, BUT NOTHING WAS NOTED. THE PHYSICIAN THEN PULLED THE WATCHMAN SHEATH INTO THE INFERIOR VENA CAVA (IVC) AND THE STAFF BEGAN COMPRESSIONS WHICH CONTINUED FOR ROUGHLY FIVE MINUTES. THE PATIENT REGAINED A RHYTHM, AND THEY BLOOD PRESSURE WAS 198/90 FROM THE COMPRESSORS. ANOTHER ECHOCARDIOGRAM NOTICED TR CHANGED FROM MODERATE TO SEVERE. THEREFORE, THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE, AND THE PATIENT GOT BROUGHT TO THE CCU - CARDIAC CARE UNIT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE TSP WAS REPORTED TO BE VERY SMOOTH. NO OTHER ISSUE WAS NOTED. NO REASON TO BELIEVE THE VERSACROSS WIRE MALFUNCTIONED, NOR THAT THE VERSACROSS WIRE OR DILATOR CONTRIBUTED TO THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 20353499 ↗
• InjurySep 18, 2024Device-Device Incompatibility; Positioning Problem; Device-Device Incompatibility; Positioning Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED, AND THE PROCEDURE WAS CANCELLED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE (LAAC) PROCEDURE. DURING THE PROCEDURE, RIGHT FEMORAL VENOUS ACCESS OBTAINED PER NORMAL PRACTICE, THUS THE WATCHMAN AND VERSACROSS CONNECT WERE INTRODUCED TO THE SUPERIOR VENA CAVA (SVC) OVER THE VERSACROSS RF WIRE. THERE WERE SEVERAL ATTEMPTS TO MAKE CONTACT WITH THE FOSSA OVALIS IN THE PROPER POSITION WHILE AVOIDING INTERACTION WITH A PREVIOUSLY IMPLANTED NON-BOSTON SCIENTIFIC ATRIAL PACER LEAD. THE PHYSICIAN WAS TRYING TO AVOID THE WATCHMAN TRANSSEPTAL/DELIVERY BEING DRAPED OVER THE PACER LEAD TO REACH THE SEPTUM. DURING THIS TIME, PRIOR TO TRANSSEPTAL ATTEMPT, A PE WAS NOTED, WHICH OCCURRED IN THE RIGHT ATRIUM (RA) WHILE MOVING TO THE FOSSA OVALIS. THE EFFUSION WAS ROUTINELY ASSESSED FOR INCREASE IN SIZE, WHICH WAS NOTED NOT TO BE INCREASING, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS LATER CANCELLED DUE TO UNSUCCESSFUL WATCHMAN IMPLANT. POST CASE, PROTAMINE WAS GIVEN TO THE PATIENT, AND THEY WERE ADMITTED TO THE HOSPITAL OVERNIGHT FOR CONTINUED OBSERVATI

  Patient problems: Pericardial Effusion

  MAUDE report 20251254 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED, AND THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, TRANSSEPTAL ACCESSED WAS ACHIEVED USING THE VERSACROSS CONNECT AND WATCHMAN DOUBLE CURVE SHEATH. WHEN THE PHYSICIAN WAS ATTEMPTING TO THEN CROSS WITH THE NON-BOSTON SCIENTIFIC ICE CATHETER (SIEMEN'S 4-D), A PERICARDIAL EFFUSION WAS OBSERVED (CIRCUMFERENTIAL PERICARDIUM). THEY MENTIONED THAT A TRACE EFFUSION WAS NOTED PRIOR TO THE PROCEDURE, WHICH HAD INCREASED IN SIZE DURING PROCEDURE, THUS A DECISION WAS MADE TO ABORT IT. A PERICARDIAL DRAIN (SUBSTERNAL) WAS THEN PLACED AND LEFT IN THE PATIENT. PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN DRAINED 1925ML OF BLOOD FROM THE DRAIN AND TRANSFUSED IT BACK INTO THE PATIENT. THE SURGERY TEAM WAS INFORMED AND CAME TO THE PROCEDURE ROOM TO DISCUSS NEXT STEPS. THE ANESTHESIOLOGIST INTUBATED THE PATIENT WHEN THE PATIENT BECAME UNSTABLE. THEY THEN PLACED AN ARTERIAL LINE AND TEMPERATURE PACER FOR BETTER MONITORING AND STABILITY. A CODE WAS CALLED, AND THE CPR WAS THEN PERFORMED, AND THE ANESTHESIOLOGIST ADMINISTERED CODE DRUGS, IN COMBINATION

  Patient problems: Pericardial Effusion

  MAUDE report 20246447 ↗
• InjurySep 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED, AND THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE VERSACROSS CONNECT AND WATCHMAN SHEAT WERE POSITIONED INTO THE SUPERIOR VENA CAVA (SVC) AND WERE DRUG DOWN TO THE SEPTUM. IT WAS TOUGH TO IMAGE THE SEPTUM. THEY WERE ABLE TO CROSS SUCCESSFULLY USING THE VERSACROSS RF WIRE (LOW AND POST POSITION), AND THE VERSACROSS RF WIRE WAS SEEN IN THE LEFT ATRIUM (LA). NEXT, THEY ADVANCED THE WATCHMAN DOUBLE CURVE SHEATH THROUGH THE SEPTUM, REQUIRING EXTRA FORCE DUE TO RESISTANCE BEING FELT. AT THIS POINT, A PE WAS NOTED IN THE POST WALL, PROTAMINE WAS GIVEN, AND THE PROCEDURE WAS CANCELLED. THEY WATCHED THE EFFUSION FOR ROUGHLY 30 MINUTES, AND NO CHANGE WAS OBSERVED. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT (ICU) FOR RECOVERY, AND IT WAS DISCHARGE FROM THE HOSPITAL. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED OF AT THE FACILITY. THE PHYSICIAN BELIEVES THEY MAY HAVE NICKED THE POSTERIOR WALL WITH THE VERSACROSS RF WIRE, RIGHT AFTER CROSSING. A TRACE OF PE WAS NOTED PRIOR TO THE PROCEDURE. NO OTHER INTER

  Patient problems: Pericardial Effusion

  MAUDE report 20171823 ↗
• InjurySep 4, 2024Display or Visual Feedback Problem; Difficult to Advance; Positioning Problem; Display or Visual Feedback Problem; Difficult to Advance; Positioning Problem

  A PERFORATION OCCURRED AND THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT PATIENT HAD A DOUBLE INTER ATRIAL SEPTUM. THE VERSACROSS CONNECT AND DOUBLE CURVE SHEATH WERE USED TO CROSS SEPTUM. ON THE FIRST TRANSSEPTAL ATTEMPT, THEY WERE ONLY ABLE TO CROSS 1 OF THE 2 SEPTUMS AND PROCEEDED TO BEGIN TENTING THE SECOND SEPTUM. ALTHOUGH, SINCE THE DESIRED LOCATION COULD NOT BE ACHIEVED, THEY DECIDED TO PULL OUT AND TRY TO RE-POSITION. ON THE 2ND ATTEMPT, TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY, BUT APPEARED TO PUNCTURE THE BACK OF THE LEFT ATRIAL WALL. THE VERSACROSS WIRE AND SHEATH WERE NOT SEEN IN THE LEFT ATRIUM AFTER TRANSSEPTAL BUT COULD BE SEEN PAST THE SEPTUM. THE PHYSICIAN THEN REMOVED THE VERSACROSS DILATOR AND ADVANCED THE WATCHMAN SHEATH ALONG WITH THE NON-BOSTON SCIENTIFIC 6F PIGTAIL CATHETER. THE PIGTAIL CATHETER WAS ALSO NOT SEEN IN THE LEFT ATRIUM. THE PHYSICIAN THEN DECIDED TO INJECT CONTRAST, WHICH FILLED THE PERICARDIAL SAC, ALLOWING THE PHYSICIAN TO CONFIRM THE PERFORATION THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20134486 ↗
• InjurySep 3, 2024Positioning Problem; Positioning Problem

  A PERFORATION, A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. THE PHYSICIAN ATTEMPTED RE-POSITION FOR TRANSSEPTAL PUNCTURE SEVERAL TIMES, AND IT WAS NEEDED TO REMOVE THE VERSACROSS DILATOR AND WAS SHEATH TWICE TO ADD CURVE, BEFORE THEY WERE ABLE TO POSITION ONTO FOSSA IN AN INFERIOR AND MID POSITION. THE RF ENERGY WAS APPLIED THREE (3) TIMES, BUT IT WAS UNSUCCESSFUL DUE TO POOR SEPTAL CONTACT. NEXT, THEY SWITCHED TO AN INFERIOR/LOW POSITION DUE TO THE PRESENCE OF MULTIPLE PACEMAKER LEAD IN THE RIGHT ATRIUM AND WERE ABLE TO GAIN TRANSSEPTAL ACCESS, CROSSING SUCCESSFULLY (UTILIZING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) VIEW TO CONFIRM CONTACT WITH THE FOSSA, THE CORRECT TSP POSITION WAS OBTAINED). THE VERSACROSS WIRE AND WATCHMAN SHEATH WERE THEN ADVANCED TO THE OSTIUM OF THE LEFT ATRIAL APPENDAGE (LAA). AT THIS POINT, THE PATIENT'S BLOOD PRESSURE BEGAN DECLINING. A (TEE) WAS THEN PERFORMED WHICH REVEALED A PE BEGINNING, AND THAT HE PATIENT'S RIGHT ATRIAL LEAD HAD MOVED FROM ITS ORIGINAL POSITION. PERICARDIOCENTESIS WAS THEN PERFORMED, STABILIZING THE PATIEN

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20128676 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERFORATION LEADING TO A PERICARDIAL EFFUSION (PE) OCCURRED AND THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN FLX PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN REPORTE THAT POST-TRANSEPTAL PUNCTURE THERE WAS A CHANGED IN HEMODYNAMICS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED FLUID BUILDUP IN THE PERICARDIAL SPACE. THE PATIENT WAS THEN TREATED WITH ANESTHESIA, A PERICARDIOCENTESIS TRAY TO ASPIRATE THE FLUID, AND A BLOOD TRANSFUSION. IT IS BELIEVED THE PE WAS CAUSED BY A PERFORATION TO THE POSTERIOR WALL. PROCEDURE WAS CANCELLED, THE PATIENT ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE, WAS WAS STABLE LEAVING THE ROOM AND IS EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). PRIOR TO THE PROCEDURE, NO PE WAS NOTED. THE PATIENT WAS NOT ON WARFARIN OR ANY ANTIPLATELET DRUGS AT THE TIME OF THE PROCEDURE. THE PHYSICIAN HAS DIFFICULTIES VISUALIZING THE IAS ON ICE AND TEE, BUT THE VERSACROSS RF WIRE WAS VISIBLE. IN THE PHYSICIAN'S OPINION, NEITHER THE VERSACROSS DILATOR NOR RF WIRE MALFUNCTIONED IN THE PROCEDURE, BUT THE LOCATION OF TRANSSEPTAL MAY HAVE CONTRIBUTED TO PUNCTURE OF WALL OF LEFT ATRIU

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19960464 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERFORATION OCCURRED, LEADING TO A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE, PROCEDURE CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE TRANSSEPTAL ACCESS WAS OBTAINED AT A MID/INFERIOR POSITION WITH NO ISSUES REPORTED, THEN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS ADVANCED ACROSS THE LEFT ATRIUM (LA), ALSO AS THE WATCHMAN SHEATH AND A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER. A PICTURE WAS THEN TAKEN, AND SHORTLY AFTER A DECREASE IN PRESSURE WAS NOTED. AT THIS POINT, A LARGE PE WAS NOTICED PRIMARILY ON THE RIGHT SIDE OF THE HEART. A PERICARDIAL TAP WAS PERFORMED, ALONG WITH REMOVING 1000ML AND GIVING BACK 900ML. THEREFORE, THE PROCEDURE WAS CANCELLED, PATIENT WAS TAKEN TO INTENSIVE CARE UNIT (ICU) FOR FURTHER MONITORING, AND IT WAS LATER DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). PRIOR TO THE PROCEDURE, THERE NO PE NOTED ON ECHO. THE PATIENT WAS NOT ON WARFARIN OR ANY ANTIPLATELET DRUGS AT THIS TIME. IN THE PHYSICIAN'S OPINION, IT WAS NOT POSSIBLE TO DETERMINE WHERE THE PERFORATION OCCURRED OR THE EXACT CAUSE OF THE PERICARDIAL EFFUSION. THE TRANSSEPTAL SITE WAS SAID TO BE IN A SAFE

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19711416 ↗
• InjuryJul 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PERFORATION, A PERICARDIAL EFFUSION AND A CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS MENTIONED THAT THE VERSACROSS CONNECT AND SHEATH WERE PLACE AT THE SUPERIOR VENA CAVA (SVC), THEN IT WAS TRACKED TOWARDS THE SEPTUM USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) GUIDANCE. A MID/MID LOCATION ON THE SEPTUM WAS NOTED BY THE PHYSICIAN AND TRANSSEPTAL WAS PERFORMED, HOWEVER, THE AORTA WAS PERFORATED. THE PATIENT HAD A PERICARDIAL EFFUSION (PE), WHICH GREW INTO A CARDIAC TAMPONADE, FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY (PEA). THE PHYSICIAN WAS ABLE TO TAP THE CHEST AND PLACE A DRAIN. THE PATIENT WAS THEN IMMEDIATELY TAKEN FOR OPEN HEART SURGERY AND HAD MASS TRANSFUSION. PATIENT WAS LAST TO BE EXTUBATED BUT STILL REMAINS IN THE ICU. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). THERE WAS NO PE NOTED PRIOR TO THE PROCEDURE. NO DIFFICULTIES WITH TRANSSEPTAL INVOLVING THE DILATOR WERE REPORTED AND THE PHYSICIAN DOES NOT BELIEVE IT CONTRIBUTED TO THE ADVERSE EVENT. ALTHOUGH, THERE WAS DIFFICULT ANATOMY WHICH MADE IT HARD TO IMAGE AND IT WAS REPO

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Perforation of Vessels; Pericardial Effusion

  MAUDE report 19703256 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A THROMBUS WAS PRESENT. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN OBTAINED FEMORAL ACCESS AND A FULL DOSE HEPARIN WAS GIVEN TO THE PATIENT. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS INSERTED TO GET BASELINE APPENDAGE MEASUREMENTS, HOWEVER A CLOT SEEMED TO BE NOTED IN THE LEFT ATRIAL APPENDAGE (LAA) WHEN LOOKING FROM THE RIGHT VENTRICULAR. THEN, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS DROPPED TO CLEAR THE APPENDAGE. AT THIS TIME, THE PHYSICIAN ASPIRATED ON VERSACROSS DILATOR AND PULLED OUT THE CLOT. THE APPENDAGE WAS CLEARED, AND PROCEDURE CONTINUED WITH NO ISSUES. THE PHYSICIAN FELT CONFIDENT THAT IT WAS APPROPRIATE TO CONTINUE PROCEDURE ONCE HE HAD SAFELY ASPIRATED AND RE-FLUSHED VERSACROSS SYSTEM AND CONTINUED TO USE THE SAME DILATOR AND WATCHMAN SHEATH. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PHYSICIAN DID NOT STATE SPECIFICALLY THAT HE FELT THAT THE VERSACROSS DEVICES CONTRIBUTED TO THE THROMBUS FORMATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19660193 ↗
• MalfunctionJul 2, 2024Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE FEMORAL ACCESS WAS GAINED TO TRACK UP TO THE SUPERIOR VENA CAVA (SVC) AND A BRIGHT ECHOGENIC FLAP WAS NOTED PRIOR TO THE TRANSSEPTAL. IT WAS INITIALLY THOUGHT THAT THERE WAS A POSSIBLE THROMBUS FORMATION ON TIP OF SHEATH, SO THE ENTIRE SYSTEM WAS WITHDRAWN OUT OF THE PATIENT'S BODY. THE SHEATH WAS ASPIRATED, AND NO THROMBUS WAS NOTED. UPON REMOVAL, IT WAS DISCOVERED THAT THE VERSACROSS RF WIRE HAD SKIVED AND FLAYED OFF FROM ITS TIP AND THE MID-SECTION OF IT. HENCE, TO RESOLVE THE ISSUE, A NEW VERSACROSS CONNECT KIT AND WATCHMAN SHEATH WERE USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE RF WIRE WAS NOT USED INTRODUCTION TO VEIN, A STARTER WIRE WAS USED INSTEAD. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659000 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED; PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY CROSS THE INTERATRIAL SEPTUM (IAS) WITH THE VERSACROSS RF PIGTAIL WIRE WITH NO ISSUES (INFERIOR AND MID/POSTERIOR). HOWEVER, SINCE THE PATIENTS IAS WAS THICK, IT CAUSED THE VERSACROSS DILATOR AND WATCHMAN SHEATH TO GET HUNG UP. IN AN ATTEMPT TO CROSS AND DILATE IT, THE PHYSICIAN INCREASED HIS FORWARD PRESSURE ON THE IAS WITH THE DEVICES, AND THEY BOTH SUDDENLY AND UNEXPECTEDLY ADVANCED THROUGH THE IAS, WHICH LEAD TO THE DILATOR WENT TOO FAR INTO THE LEFT ATRIUM (LA) AND PERFORATED THE POSTERIOR WALL OF THE LA. THE TIP OF THE VERSACROSS RF WIRE WAS PROTRUDING OUT OF THE DILATOR AT THIS TIME. A PERICARDIAL EFFUSION WAS IMMEDIATELY NOTICED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY, INDICATING A CARDIAC TAMPONADE. THE PROCEDURE WAS THEN CANCELLED. THEREFORE, A CARDIOTHORACIC (CT) SURGEON WAS IMMEDIATELY NOTIFIED, AND HEPARIN WAS REVERSED. THE PHYSICI

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19610174 ↗
• InjuryJun 25, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED; PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY CROSS THE INTERATRIAL SEPTUM (IAS) WITH THE VERSACROSS RF PIGTAIL WIRE WITH NO ISSUES (INFERIOR AND MID/POSTERIOR). HOWEVER, SINCE THE PATIENTS IAS WAS THICK, IT CAUSED THE VERSACROSS DILATOR AND WATCHMAN SHEATH TO GET HUNG UP. IN AN ATTEMPT TO CROSS AND DILATE IT, THE PHYSICIAN INCREASED HIS FORWARD PRESSURE ON THE IAS WITH THE DEVICES, AND THEY BOTH SUDDENLY AND UNEXPECTEDLY ADVANCED THROUGH THE IAS, WHICH LEAD TO THE DILATOR WENT TOO FAR INTO THE LEFT ATRIUM (LA) AND PERFORATED THE POSTERIOR WALL OF THE LA. THE TIP OF THE VERSACROSS RF WIRE WAS PROTRUDING OUT OF THE DILATOR AT THIS TIME. A PERICARDIAL EFFUSION WAS IMMEDIATELY NOTICED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY, INDICATING A CARDIAC TAMPONADE. THE PROCEDURE WAS THEN CANCELLED. THEREFORE, A CARDIOTHORACIC (CT) SURGEON WAS IMMEDIATELY NOTIFIED, AND HEPARIN WAS REVERSED. THE PHYSICI

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19610155 ↗
• MalfunctionJun 18, 2024Defective Device; Material Deformation; Defective Device; Material Deformation

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. DURING INSERTION, THE VERSACROSS DILATOR TIP WAS NOTICED TO BE KINKED AND DAMAGED (BREAK) ON LOADING IT TO THE WIRE. THUS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS MENTIONED THAT THE METHOD OF LOADING THE DEVICE COULD POSSIBLY HAVE CAUSED THE DAMAGE ON THE VERSACROSS DILATOR. THE DILATOR WAS NOT RESHAPED PRIOR TO THE DAMAGE NOTED. THE DEVICE IS NOT EXPECTED TO BE RETURN AS DISPOSED IN FACILITY (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562780 ↗
• InjuryJun 12, 2024Material Deformation; Material Deformation

  A PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE VENOUS ACCESS WAS OBTAINED IN THE RIGHT FEMORAL VEIN AND A NON-BOSTON SCIENTIFIC 6 FR. SHEATH WAS INSERTED. THE VERSACROSS RF WIRE WAS INSERTED AND ADVANCED TO THE SUPERIOR VENA CAVA (SVC), AND DURING ADVANCEMENT, THE VERSACROSS RF WIRE INITIALLY TRIED TO TRACK INTO THE RIGHT HEPATIC VEIN BUT WAS SUCCESSFULLY ADVANCED TO THE SVC. THEN, NON-BOSTON SCIENTIFIC 6 FR. SHEATH WAS EXCHANGED, THE TIP OF THE VERSCACROSS RF WIRE WAS RETRACTED INTO THE VERSACROSS DILATOR AND A DROP DOWN TO THE FOSSA OVALIS WAS PERFORMED. ONCE THE DESIRED PUNCTURE LOCATION WAS OBTAINED, THE TRANSSEPTAL CROSSING WAS COMPLETED. THE VERSACROSS RF WIRE WAS THEN ADVANCED BLINDLY INTO THE LEFT ATRIUM. ONCE THE RF COIL OF THE WIRE WAS LOCATED, IT WAS FOUND TO BE IN THE WALL OF THE LEFT ATRIAL APPENDAGE, WITH THE PIGTAIL TIP PARTIALLY DISTORTED IN SHAPE. THE SHEATH AND DILATOR WERE THEN ADVANCED ACROSS THE SEPTUM, FOLLOWED BY THE DILATOR BEING REMOVED. A NON-BOSTON SCIENTIFIC 6 FR PIGTAIL CATHETER WAS THEN INSERTED OVER THE VERSACROSS RF W

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19523370 ↗
• InjuryJun 10, 2024Positioning Problem; Positioning Problem

  A PERFORATION AND A PERICARDIAL EFFUSION (PE) WERE REPORTED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. POST PROCEDURE, APPROXIMATELY 30 MINUTES AFTER SUCCESSFUL WATCHMAN DEPLOYMENT, THE PATIENT BECAME HYPOTENSIVE. UPON FURTHER EXAMINATION, A PERFORATION WAS DISCOVERED IN THE LEFT ATRIUM (LA). THUS, A PERICARDIOCENTESIS WAS PERFORMED TO MANAGE THE EFFUSION, FOLLOWED BY CARDIOTHORACIC (CT) SURGICAL INTERVENTION. PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE, AND IT WAS LATER DISCHARGED. THE PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT WAS ALSO REPORTED THAT MULTIPLE ATTEMPTS REQUIRED TO TRACK UP / DROP DOWN INTO POSITION ON SEPTUM BEFORE TSP SINCE THE SEPTUM WAS EXTREMELY ANEURYSMAL SO IT TOOK SOME TIME TO FIND THE SPOT TO CROSS. DUE TO THE SAME REASON, TENTING WAS VERY HEAVY, THUS EXTRA CAUTION WAS TAKEN DURING THE TRANSSEPTAL. LIKELY PERFORATION OCCURRED DURING THIS PORTION OF THE CASE SINCE IT WAS CLOSE TO BACK WALL DURING TENTING. TWO APPLICATIONS OF RADIO FREQUENCY WERE NEEDED, SINCE IT WAS NOT POSSIBLE TO CROSS IN THE FIRST TIME. THERE IS A POTEN

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19498660 ↗
• InjuryJun 10, 2024Difficult to Advance; Difficult to Advance

  A PERFORATION AND A PERICARDIAL EFFUSION (PE) WERE REPORTED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. POST PROCEDURE, APPROXIMATELY 30 MINUTES AFTER SUCCESSFUL WATCHMAN DEPLOYMENT, THE PATIENT BECAME HYPOTENSIVE. UPON FURTHER EXAMINATION, A PERFORATION WAS DISCOVERED IN THE LEFT ATRIUM (LA). THUS, A PERICARDIOCENTESIS WAS PERFORMED TO MANAGE THE EFFUSION, FOLLOWED BY CARDIOTHORACIC (CT) SURGICAL INTERVENTION. PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE, AND IT WAS LATER DISCHARGED. THE PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT WAS ALSO REPORTED THAT MULTIPLE ATTEMPTS REQUIRED TO TRACK UP / DROP DOWN INTO POSITION ON SEPTUM BEFORE TSP SINCE THE SEPTUM WAS EXTREMELY ANEURYSMAL SO IT TOOK SOME TIME TO FIND THE SPOT TO CROSS. DUE TO THE SAME REASON, TENTING WAS VERY HEAVY, THUS EXTRA CAUTION WAS TAKEN DURING THE TRANSSEPTAL. LIKELY PERFORATION OCCURRED DURING THIS PORTION OF THE CASE SINCE IT WAS CLOSE TO BACK WALL DURING TENTING. TWO APPLICATIONS OF RADIO FREQUENCY WERE NEEDED, SINCE IT WAS NOT POSSIBLE TO CROSS IN THE FIRST TIME. THERE IS A POTEN

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19498645 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, THE PHYSICIAN WENT UP WITH THE VERSACROSS DEVICE AND WATCHMAN SHEATH, ALONG WITH A GOOD IMAGE OF THE FOSSA OVALIS WITH THE APPENDAGE IN THE 5'OCLOCK VIEW. ONCE MAXIMUM TENTING WAS ACHIEVED ON THE SEPTUM ON THE LOWER PART OF THE FOSSA IN A SAFE LOCATION, TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED, AND THE VERSACROSS RF WIRE WENT INTO THE APPENDAGE. THE PHYSICIAN THEN USED THE VXA/WAS TO DILATE THE SEPTUM SO HE COULD GET ICE ACROSS. THEN, THE ICE CATHETER ADVANCED ACROSS AND BEGAN GETTING MEASUREMENTS/IMAGES OF THE APPENDAGE FROM THE LEFT SIDE OF THE HEART. SPONTANEOUSLY, THE PHYSICIAN LOST THE LEFT ATRIUM (LA) ACCESS AND FELL BACK INTO THE RIGHT ATRIUM. IN RESPONSE, THEY BEGAN MANIPULATING THE ICE CATHETER TO GO TO THE LEFT SIDE, AND UPON DOING SO, THEY NOTICED A PERICARDIAL EFFUSION (PE) ON THE RIGHT SIDE OF THE HEART. A PERICARDIOCENTESIS WAS THEN PERFORMED TO DRAIN THE FLUID AND THE CARDIOVASCULAR SURGEON WAS CALLED. HOWEVER, THE PATIENT WAS S

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19212879 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. A PERICARDIAL EFFUSION OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, THE VENOUS ACCESS WAS OBTAINED AND THE TRANSSEPTAL PUNCTURE WAS COMPLETED SUCCESSFULLY. THUS, THE WAS DOUBLE CURVE GOT ACROSS SEPTUM AND AN EFFUSION SWEEP IDENTIFIED A PERICARDIAL EFFUSION (PE) AROUND THE LEFT VENTRICLE THAT WAS NOT PREVIOUSLY NOTED. THEREFORE, A PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS THEN CANCELLED PRIOR TO ANY DEVICE IMPLANT. PATIENT HAS BEEN ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE AND IS EXPECTED TO FULLY RECOVER. PRODUCTS WILL NOT BE RETURNING FOR ANALYSIS. PRIOR TO THE PROCEDURE, NO PE WAS NOTED ON ECHO. THE PATIENT WAS NOT ON WARFARIN OR ANTIPLATELET DRUGS AT THIS TIME. IT HAS BEEN FURTHER MENTIONED THAT THE PATIENT HAD A TORTUOUS VENA CAVA SYSTEM AND THAT MULTIPLE ATTEMPTS WERE REQUIRED TO TRACK UP / DROP DOWN BEFORE TRANSSEPTAL. ACT WAS NOTED TO BE 358 DURING THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THERE IS NO REASON TO BELIEVE THAT THE VERSACROSS RF WIRE AND DILATOR MALFUNCTIONED DURING THE PROCEDURE OR CONTRIBUT

  Patient problems: Pericardial Effusion

  MAUDE report 19200899 ↗
• InjuryApr 26, 2024Positioning Problem; Positioning Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. A PERICARDIAL EFFUSION OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, THE VENOUS ACCESS WAS OBTAINED AND THE TRANSSEPTAL PUNCTURE WAS COMPLETED SUCCESSFULLY. THUS, THE WAS DOUBLE CURVE GOT ACROSS SEPTUM AND AN EFFUSION SWEEP IDENTIFIED A PERICARDIAL EFFUSION (PE) AROUND THE LEFT VENTRICLE THAT WAS NOT PREVIOUSLY NOTED. THEREFORE, A PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS THEN CANCELLED PRIOR TO ANY DEVICE IMPLANT. PATIENT HAS BEEN ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE AND IS EXPECTED TO FULLY RECOVER. PRODUCTS WILL NOT BE RETURNING FOR ANALYSIS. PRIOR TO THE PROCEDURE, NO PE WAS NOTED ON ECHO. THE PATIENT WAS NOT ON WARFARIN OR ANTIPLATELET DRUGS AT THIS TIME. IT HAS BEEN FURTHER MENTIONED THAT THE PATIENT HAD A TORTUOUS VENA CAVA SYSTEM AND THAT MULTIPLE ATTEMPTS WERE REQUIRED TO TRACK UP / DROP DOWN BEFORE TRANSSEPTAL. ACT WAS NOTED TO BE 358 DURING THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THERE IS NO REASON TO BELIEVE THAT THE VERSACROSS RF WIRE AND DILATOR MALFUNCTIONED DURING THE PROCEDURE OR CONTRIBUT

  Patient problems: Pericardial Effusion

  MAUDE report 19197790 ↗