VersaCross Connect LAAC Access Solution VXAK0003 (UDI 00685447018346)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00685447018346), received between Oct 29, 2024 and Nov 24, 2025 — classified as 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A CARDIAC PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC WAS SELECTED FOR USE. A MILD EFFUSION ON THE RIGHT SIDE OF THE HEART WAS NOTED DURING PRE-IMAGING. THE PHYSICIAN EXPERIENCED DIFFICULTY ACCESSING SUPERIOR VENA CAVA (SVC) WITH A NON-BOSTON SCIENTIFIC (WHOLLY) WIRE AND SUBSEQUENTLY THE VERSACROSS CONNECT RF WIRE. AT MULTIPLE POINTS THE WIRE WAS EXPOSED OUTSIDE OF THE DILATOR, BUT WITHOUT THE FULL CURL OF THE PIGTAIL. PRIOR TO TRANSSEPTAL, A LARGER EFFUSION NOTED IN MOST ANGLES OF THE HEART AND CHANGE IN HEART MOTION WAS NOTED BY THE CLINICAL SPECIALIST PROMPTING FURTHER INVESTIGATION BY THE PHYSICIAN AND ECHOCARDIOLOGIST. IT WAS AGREED THAT THE EFFUSION HAD GROWN, BUT THE IMPLANTING PHYSICIAN WANTED TO CONTINUE THE PROCEDURE AS LONG AS THE PATIENT REMAINED STABLE. PRESSURE DROPPED SLIGHTLY, BUT WAS STABLE WITH MEDICATION. THE WATCHMAN PROCEDURE WAS COMPLETED AND THE EFFUSION REMAINED STABLE THROUGHOUT. AFTER RELEASE OF THE DEVICE, THE EFFUSION WAS WATCHED FOR TEN TO FIFTEEN MINUTES AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT FOR FURTHER MONITORING.

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

  MAUDE report 23638027 ↗
• MalfunctionJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE VERSACROSS DILATOR WAS RETURNED WITH NO REPORTED DEVICE ALLEGATIONS OR PATIENT COMPLICATIONS. THE USER MENTIONED THAT THE VEINS GOING UP THE GROIN TO THE RIGHT ATRIUM WERE VERY TORTUOUS. THE RF WIRE AND VERSACROSS DILATOR WERE ADVANCED INTO THE SVC, ALONG WITH THE TRUSTEER SHEATH. THEY MENTIONED THAT THEY HAD TO DROP DOWN A FEW TIMES BEFORE THE PHYSICIAN DECIDED TO PULL OUT THE DILATOR IN ORDER TO MANIPULATE THE CURVE. DURING THIS ACTION, THEY BELIEVE THAT THE RF WIRE MAY HAVE ALSO UNINTENTIONALLY SLIPPED BACK INTO THE SHEATH AND GOT CAUGHT IN A SIDEHOLE OF THE TRUSTEER SHEATH TIP. THEN, WHEN THE DILATOR WAS RE-ADVANCED, THE WIRE PRESUMABLY MUST HAVE PUSHED THROUGH THE SHEATH TIP AND CAUSED IT TO TEAR. THE CASE WAS CONTINUE AND COMPLETED SUCCESSFULLY AS THE ISSUE WAS ONLY NOTED WHEN THE DEVICES WERE REMOVED. THEY ALSO MENTIONED THAT THE DILATOR WENT ACROSS THE FOSSA WITH NO ISSUES, BUT THE SHEATH TOOK A LOT MORE FORCE TO GET ACROSS THE SEPTUM. UPON PRODUCT RETURN, ANALYSIS CONFIRMED DILATOR TIP HAS A SLICE THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125713 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A THROMBOSIS WAS NOTED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE INDICATED FOR BLEEDS, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. BASELINE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED PRIOR TO GETTING ACCESS AND THERE WAS NO THROMBUS VISUALIZED IN LEFT ATRIAL APPENDAGE (LAA) OR IN RIGHT ATRIUM. THE VERSACROSS CONNECT RF PIGTAIL WIRE WAS ADVANCED TO THE SUPERIOR VENA CAVA (SVC) AND THE TRUSTEER SHEATH WAS ADVANCED TO THE RIGHT ATRIUM. WHEN THE PHYSICIAN PULLED THE WIRE AND SHEATH DOWN TO PREPARE FOR TRANSEPTAL, A LARGE THROMBUS WAS VISUALIZED WHICH DISLODGED. ALL DEVICES WERE REMOVED. THE PULMONARY ARTERIES WERE ASSESSED AND THE CLOT WAS VISUALIZED IN THE RIGHT PULMONARY ARTERY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PHYSICIAN DECIDED TO MEDICALLY MANAGE RATHER THAN REMOVING THE CLOT BECAUSE THE PATIENT HAS A PFO. IN THE PHYSICIAN OPINION, THE PATIENT RECENTLY HAD A PACEMAKER PUT IN (B)(6) 2025 AND THE PHYSICIAN THINKS THE PATIENT HAD A THROMBUS ON THE PACEMAKER LEAD IN THE SVC WHICH IS WHY IT WAS NOT VISUALIZED ON TEE. THE PATIENT IS DOING WELL. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PATIENT WA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22096566 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A THROMBOSIS HAS OCCURRED. THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. DURING THE PROCEDURE A TRANSEPTAL PUNCTURE WAS PERFORMED WITH A VERSACROSS CONNECT AND TRUSTEER SHEATH. WHEN THE VERSACROSS RF WIRE WAS REMOVED, A MOBILE OBJECT WAS NOTED ON THE TIP OF THE COUMADIN RIDGE. IT WAS NOT POSSIBLE TO DETERMINE WHETHER IT WAS A TISSUE FRAGMENT OR A THROMBUS. THE PHYSICIAN DECIDED TO KEEP THE PATIENT ON ORAL ANTICOAGULATION (OAC) AND RESCHEDULE THE PROCEDURE ON A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). HALF DOSE OF HEPARIN WAS GIVEN BEFORE TRANSSEPTAL AND HALF WAS GIVEN AFTER. ACT WAS MEASURED AS 307 SECONDS. THE PATIENT WAS SENT HOME SAME DAY. THE PHYSICIANS WANT TO KEEP THE PATIENT ON OAC AND RE-IMAGE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22019067 ↗
• InjuryMar 18, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A CARDIAC TAMPONADE, PERICARDIAL EFFUSION AND PERFORATION WERE NOTED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE USER MENTIONED THAT THEY HAD TO REWIRE A FEW TIMES TO GET THE RIGHT TRANSSEPTAL. EVENTUALLY, THE WIRE CROSSED THE SEPTUM WHILE TENTING, NO RF APPLICATION PERFORMED. AT THIS POINT, THE PATIENT HAD A SLIGHT DROP IN BLOOD PRESSURE AND A CIRCUMFERENTIAL EFFUSION WAS NOTICED. THE EFFUSION WAS MONITORED, AND SINCE IT DID ENLARGE, THE PHYSICIAN FELT COMFORTABLE CONTINUING WITH THE PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY IN ONE ATTEMPT WITH THE WATCHMAN DEVICE. AFTER RELEASING THE DEVICE, THEY CHECKED THE EFFUSION AGAIN AND STATED THAT IT MAY HAVE GOTTEN LARGER AND PROCEEDED TO PERFORM PERICARDIOCENTESIS. UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE PATIENT HAD EVEN LOWER BLOOD PRESSURE AND A SLIGHT CARDIAC TAMPONADE. IN ADDITION, THE PHYSICIAN BELIEVES THAT THE ICE CATHETER MAY HAVE CAUSED A PERFORATION. PATIENT WAS SENT FOR ADDITIONAL SURGERY AND IS EXPECTED TO FULLY RECOVER. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). NO PERICARDIAL EFFUSION WAS NOTE

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

  MAUDE report 21632508 ↗
• InjuryMar 11, 2025Positioning 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 WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE PERICARDIAL SPACE WAS INADVERTENTLY ACCESSED DURING ATTEMPTED TRANSSEPTAL CROSSING. THE VERSACROSS RF WIRE WAS PULLED BACK AND READVANCED MULTIPLE TIMES INTO THE RIGHT ATRIUM AND A PE WAS NOTED BY TRANSESOPHAGEAL ECHOCARDIOGRAM, POSTERIOR TO THE LEFT VENTRICLE. THE EFFUSION APPEARED STABLE AFTER MONITORING AND PATIENT'S VITAL SIGNS WERE UNCHANGED. A DECISION WAS MADE TO IMPLANT THE WATCHMAN DEVICE AND PLACE A PERICARDIAL DRAIN AT THE END OF THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS REATTEMPTED SUCCESSFULLY AND WATCHMAN DEVICE PLACED WITHOUT INCIDENT, MEETING PASS CRITERIA. ONCE WATCHMAN ACCESS SHEATH WAS REMOVED, HEPARIN WAS REVERSED WITH PROTAMINE AND THE PHYSICIAN PROCEEDED WITH PERICARDIOCENTESIS/DRAIN PLACEMENT. A TOTAL OF 120 ML OF SANGUINOUS/BLOOD COLORED FLUID DRAINED BY ASPIRATION. THE EFFUSION WAS RESOLVED, AND THE DRAIN WAS LEFT IN PLACE TO MONITOR FOR 24 HOURS BEFORE REMOVING. THE PATIENT WAS HOSPITALIZED BEYOND STANDARD OF CARE AND IT IS EXPECTED TO FULLY RECOVER. PRODUCT IS NOT EXPECTED TO R

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 21574257 ↗
• MalfunctionFeb 24, 2025Material Perforation; Material Perforation

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. WHEN THE DILATOR WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THAT ITS TIP WAS DEFORMED/RIPPED. THE DILATOR WAS NOT INSERTED INTO A SHEATH PRIOR TO THE DAMAGE BEING NOTED. THERE WAS NO DAMAGE SEEN ON THE PACKAGING ITSELF AND THE DILATOR WAS NOT DAMAGED DURING REMOVAL. THE DEVICE WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21449734 ↗
• InjuryFeb 18, 2025Difficult to Advance; Positioning Problem; Difficult to Advance; 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 WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE PERICARDIAL SPACE WAS INADVERTENTLY ACCESSED DURING ATTEMPTED TRANSSEPTAL CROSSING. THE VERSACROSS RF WIRE WAS PULLED BACK AND READVANCED MULTIPLE TIMES INTO THE RIGHT ATRIUM AND A PE WAS NOTED BY TRANSESOPHAGEAL ECHOCARDIOGRAM, POSTERIOR TO THE LEFT VENTRICLE. THE EFFUSION APPEARED STABLE AFTER MONITORING AND PATIENT'S VITAL SIGNS WERE UNCHANGED. A DECISION WAS MADE TO IMPLANT THE WATCHMAN DEVICE AND PLACE A PERICARDIAL DRAIN AT THE END OF THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS REATTEMPTED SUCCESSFULLY AND WATCHMAN DEVICE PLACED WITHOUT INCIDENT, MEETING PASS CRITERIA. ONCE WATCHMAN ACCESS SHEATH WAS REMOVED, HEPARIN WAS REVERSED WITH PROTAMINE AND THE PHYSICIAN PROCEEDED WITH PERICARDIOCENTESIS/DRAIN PLACEMENT. A TOTAL OF 120ML OF SANGUINOUS/BLOOD COLORED FLUID DRAINED BY ASPIRATION. THE EFFUSION WAS RESOLVED, AND THE DRAIN WAS LEFT IN PLACE TO MONITOR FOR 24 HOURS BEFORE REMOVING. THE PATIENT WAS HOSPITALIZED BEYOND STANDARD OF CARE AND IT IS EXPECTED TO FULLY RECOVER. PRODUCT IS NOT EXPECTED TO RE

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 21405688 ↗
• InjuryFeb 10, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED AND THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. DURING THE PROCEDURE, WHEN ATTEMPT WAS MADE FOR TRANSSEPTAL USING VERSACROSS RF WIRE, IT FAILED TO CROSS, AND NO BUBBLES WERE NOTED IN LEFT ATRIUM (LA). SO, A SECOND ATTEMPT WAS MADE TO CROSS, AND BUBBLES WERE SEEN, HOWEVER, THE VERSACROSS RF WIRE DID NOT CROSS. A THIRD ATTEMPT WAS MADE AND SAME ISSUE NOTED. THE PHYSICIAN TRIED DIFFERENT POSITIONING ON SEPTUM BY PUTTING MORE BEND ON VERSACROSS DILATOR. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS CHECKED, AND A PERICARDIAL EFFUSION WAS NOTED AROUND RIGHT VENTRICLE. PATIENT BLOOD PRESSURE WAS DROPPED WHEN PE HAD OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED DUE TO HEMODYNAMIC COMPROMISE AND 360 CC DARK RED BLOOD WAS REMOVED. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE AND EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS CONFIRMED THAT HEPARIN WAS GIVEN JUST PRIOR TO TRANSSEPTAL PUNCTURE. NO VERSACROSS DEVICE MALFUNCTIONS WERE REPORTED. IT WAS NOTED A DIFFICULT VISU

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 21349842 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT AFTER INSERTING THE VERSACROSS RF WIRE THROUGH A NON-BOSTON SCIENTIFIC INTRODUCER NEEDLE, THE TIP OF THE RF WIRE WAS NOTED TO BE STRIPPED ONCE IT WAS REMOVED. IT WAS PEELED BACK NEAR THE DISTAL END, BUT STILL INTACT. HENCE, A NEW KIT WAS THEN OPENED TO BE USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE HAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313193 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN LOST LEFT ATRIUM ACCESS FROM THE FIRST TRANSSEPTAL HENCE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS PULLED BACK TO RIGHT ATRIUM (RA). THE SECOND TRANSSEPTAL WAS COMPLETED. THE PHYSICIAN ADVANCED THE SHEATH AND DILATOR INTO LEFT ATRIUM. ICE WAS THEN MOVED INTO RIGHT VENTRICULAR OUT PULMONIC VALVE INTO THE PULMONARY ARTERY (PA). THE APPENDAGE WAS VISUALIZED TO CONFIRM SHEATH AND DILATOR ACCESS IN LEFT ATRIUM (LA). BOTH SHEATH AND DILATOR WERE VISUALIZED NEAR APPENDAGE. PHYSICIAN PULLED ICE BACK OUT TOWARDS RA FROM PA WHEN EFFUSION WAS VISUALIZED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, EXPECTED TO MAKE FULL RECOVERY, AND WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. THE PATIENT HAS BEEN DISCHARGED LATER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PATIENT WAS NOT UNDER WARFARIN NOR ANTIPLATELET DRUGS AT THE TIME. THE LA LOST ACCESS HAPPENED DURING MANIPULATION WITH WAS, TRYING TO ENGAGE WITH LEFT ATRIUM APP

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 21118443 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN LOST LEFT ATRIUM ACCESS FROM THE FIRST TRANSSEPTAL HENCE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS PULLED BACK TO RIGHT ATRIUM (RA). THE SECOND TRANSSEPTAL WAS COMPLETED. THE PHYSICIAN ADVANCED THE SHEATH AND DILATOR INTO LEFT ATRIUM. ICE WAS THEN MOVED INTO RIGHT VENTRICULAR OUT PULMONIC VALVE INTO THE PULMONARY ARTERY (PA). THE APPENDAGE WAS VISUALIZED TO CONFIRM SHEATH AND DILATOR ACCESS IN LEFT ATRIUM (LA). BOTH SHEATH AND DILATOR WERE VISUALIZED NEAR APPENDAGE. PHYSICIAN PULLED ICE BACK OUT TOWARDS RA FROM PA WHEN EFFUSION WAS VISUALIZED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, EXPECTED TO MAKE FULL RECOVERY, AND WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. THE PATIENT HAS BEEN DISCHARGED LATER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PATIENT WAS NOT UNDER WARFARIN NOR ANTIPLATELET DRUGS AT THE TIME. THE LA LOST ACCESS HAPPENED DURING MANIPULATION WITH WAS, TRYING TO ENGAGE WITH LEFT ATRIUM APP

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 21118442 ↗
• MalfunctionJan 8, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. DURING PREPARATION, UPON OPENING THE PACKAGING FOR THE VERSACROSS CONNECT IT WAS NOTED THAT THE DISTAL TIP OF THE DILATOR WAS DAMAGED, LIKE A RIP. THUS, A NEW KIT WAS OPENED TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT RETURN IS EXPECTED. IT SAYS THAT THE MATERIAL WAS BUCKLED, PRIOR TO ADVANCE INTO THE SHEATH. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103464 ↗
• InjuryDec 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN PROCEDURE INDICATED FOR A CASE OF GASTROINTESTINAL BLEEDING (GIB), A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED, TRANSSEPTAL PUNCTURE WAS COMPLETED. A POSTERIOR EFFUSION WAS NOTED IMMEDIATELY AFTER TRANSSEPTAL PUNCTURE. THE WATCHMAN FLX DEVICE WAS SUCCESSFUL DEPLOYED. AFTERWARDS THE EFFUSION HAD GROWN TO AROUND 1.8CM AND PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN FELT HE HAD NO EXPLANATION FOR THE EFFUSION. IT WAS THEORIZED THAT IN AN EFFORT TO AVOID PACEMAKER WIRES, THE PHYSICIAN MAY HAVE NICKED SOMETHING WITH THE RF WIRE OR WITH ICE CATHETER, OR THE TRANSEPTAL WAS MORE INFERIOR. THE PATIENT WAS DOING WELL IN THE HOSPITAL AND EXPECTED TO BE DISCHARGED COUPLE OF DAYS LATER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFARIN NOR ANTIPLATELET DRUGS AT THE TIME. IN THE PHYSICIAN'S OPINION, THE DEVICE/PROCEDURE DID NOT CONTRIBUTE TO THE PATIENT COMPLICATION. IT WAS FURTHER CONFIRMED THAT THE VERSACROSS DEVICE DID NOT MALFUNCTION OR SEEMED TO CONTRIBUTE TO PATIENT

  Patient problems: Pericardial Effusion

  MAUDE report 20988588 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. VENOUS ACCESS WAS OBTAINED AND TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED USING VERSACROSS CONNECT (VCC) TRANSSEPTAL ACCESS SYSTEM THROUGH A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WHICH WAS THEN ADVANCED INTO THE LEFT ATRIUM. A WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS IMPLANTED. A PE WAS NOTED DURING THE PROCEDURE, REQUIRING A PERICARDIOCENTESIS TO BE PERFORMED. THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE, FULLY RECOVERED AND DISCHARGED HOME ON (B)(6) 2024. THE PRODUCT IS NOT RETURNING FOR ANALYSIS (DISPOSED). IN THE PHYSICIAN OPINION, THE DEVICE OR PROCEDURE DID CONTRIBUTE TO THE PATIENT COMPLICATION DUE TO THE PUNCTURE SITE.

  Patient problems: Pericardial Effusion

  MAUDE report 20887147 ↗
• InjuryNov 14, 2024Material Deformation; Material Deformation

  A PERFORATION HAS OCCURRED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. IT WAS NOTED THAT WHEN ADVANCING THE VERSACROSS WIRE IN THE RIGHT ATRIUM, IT WENT TO THE PATIENT'S LEFT SIDE AND ENTERED THE LEFT RENAL VEIN CAUSING A VASCULAR INJURY. THE VERSACROSS RF WIRE WAS PULLED BACK AND READVANCED, AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THUS, THE VASCULAR INJURY WAS REPAIRED. THE PATIENT HAS BEEN DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE WIRE WAS KINKED AT SOME POINT WHEN ADVANCING INTO THE BODY.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 20689220 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. VENOUS ACCESS WAS OBTAINED AND TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED. A WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WD) WAS ADVANCED AND POSITIONED AT THE LAA THEN SUBSEQUENTLY DEPLOYED AND IMPLANTED. THE PROCEDURE WAS CONCLUDED. DURING THE SAME DAY OF THE INDEX PROCEDURE, A PE WAS NOTED. ACCORDING TO THE PHYSICIANS, THE PE WAS DUE TO ATTEMPTED TSP. NO FURTHER DETAILS WERE REPORTED. IT WAS FURTHER REPORTED THE CLOSURE DEVICE WAS A 27MM WATCHMAN FLX PRO. THE PATIENT WAS ENROLLED INTO THE HEAL-LAA STUDY ON (B)(6) 2024 AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE PROCEDURE, HEPARIN WAS ADMINISTERED. A WATCHMAN TRUSTEER ACCESS SYSTEM WAS ALSO USED IN THE PROCEDURE. THE PE WAS NOTED TO BE CAUSED BY THE PROCEDURE ON THE SAME DAY OF THE INDEX PROCEDURE. THE PE NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM IMAGING (TEE) WAS 11 MM IN SIZE. THE PATIENT STARTED TAKING ASPIRIN AND CLOPIDOGREL MEDICATIONS THE SAME DAY OF THE INDEX PROCEDURE AND WAS SUBSEQUENTLY DISCHARGED THE FOLLOWING DAY. AFTER 11 DAYS POST BEING DISCHARGED HOME, THE PATIENT WA

  Patient problems: Pericardial Effusion

  MAUDE report 20558660 ↗