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

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00685447010524), received between Oct 11, 2024 and Nov 5, 2025 — classified as 2 deaths, 35 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (8 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM, ST SEGMENT ELEVATION OCCURRED AND PATIENT EXPERIENCED CARDIAC ARREST. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PATIENT HAD HISTORY OF RENAL TRANSPLANT AND ESOPHAGEAL VARICES. THERE WAS A SMALL PERICARDIAL EFFUSION PRESENT AT BASELINE PRIOR TO THE CASE. THE PHYSICIAN DID NOT WANTED TO INTUBATE THE PATIENT DUE TO ESOPHAGEAL VARICES AND THEREFORE AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) PROCEDURE WAS DONE. THE ICE CATHETER WAS INSERTED WITHOUT ISSUE. THE PHYSICIAN INSERTED THE WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WITH THE VERSACROSS CONNECT AND THE TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED. THE VERSACROSS DILATOR WAS THEN REMOVED BUT THE RF WIRE REMAINED IN THE BODY. POST INSERTION OF THE WAS AFTER THE VERSACROSS DILATOR WAS REMOVED, THE PATIENT TOOK A HUGE BREATH WHICH RESULTED IN AN AIR EMBOLISM IN THE PATIENT'S CORONARIES. THE PATIENT WENT INTO ASYSTOLE AND INTO CARDIAC ARREST. THE PATIENTS HEART WAS MASSAGED; THEY WERE GIVEN ATROPINE AND A LEAD WAS PLACED TO RE-ACTIVATE THE HEART. THE PATIENT WAS INTUBATED AND WAS GOING TO UNDERGO A COMPUTED TO

  Patient problems: Air Embolism; Asystole; Cardiac Arrest; Cardiac Tamponade; Non specific EKG/ECG Changes; Pericardial Effusion

  MAUDE report 23477692 ↗
• InjuryAug 28, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A TISSUE SWELLING NEAR AORTA WAS NOTED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PHYSICIAN WAS EXPERIENCING DIFFICULTY WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGES DUE TO PATIENT'S ANATOMY. DURING THE TRANSSEPTAL PART OF THE PROCEDURE, THE WATCHMAN SHEATH AND VERSACROSS CONNECT WAS VISUALIZED TENTING THE SEPTUM IN A MEDIAL POSITION IN THE SHORT AXIS VIEW ON TEE. DECENT AMOUNT OF TENTING ON TEE WAS SEEN. ECHO PHYSICIAN CONFIRMED THE AREA LOOKED BETTER. THE PHYSICIAN FELT THAT IT WAS SAFE TO CROSS IN THIS POSITION AND HAD THE CIRCULATING NURSE PRESS THE RADIO FREQUENCY (RF) BUTTON ON THE BMC RF GENERATOR. THE PHYSICIAN WAS ABLE TO ADVANCE THE WIRE WITHOUT ANY RESISTANCE HOWEVER THE IMAGING PHYSICIAN WAS UNABLE TO VISUALIZE THE WIRE IN THE LEFT ATRIUM. THE PHYSICIAN DECIDED TO PULL THE WIRE BACK INTO THE RIGHT ATRIUM/INFERIOR VENA CAVA (IVC). IT WAS OBSERVED A SWOLLEN PART OF TISSUE THAT WAS BELIEVED TO NOT BE THERE PRIOR TO TRANSSEPTAL. IT WAS DECIDED TO ABORT THE WATCHMAN PROCEDURE AND TO REVERSE THE HEPARIN THAT WAS GIVEN. THE PHYSICIAN MONITORED THE AREA FOR TE

  Patient problems: Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 22913821 ↗
• InjuryAug 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PATIENT HAD A PACEMAKER AND HISTORY OF VON WILLEBRAND DISEASE. THE TRANSEPTAL PUNCTURE (TSP) WAS COMPLETED IN AN INFERIOR/MID LOCATION ON THE FOSSA USING INTRACARDIAC ECHO (ICE) GUIDANCE. THE PHYSICIAN HAD CHALLENGES GETTING THE VERSACROSS WIRE PAST THE PACER LEADS AND HAD TO REDIRECT SEVERAL TIMES. AFTER GETTING ACROSS TO LEFT SIDE, THE 27MM WATCHMAN DELIVERY SYSTEM (WDS) WAS ADVANCED AND DEPLOYED. IT WAS NOTED THAT THE WDS WAS TOO SMALL AND HAD LOW COMPRESSION. THE WDS WAS REMOVED AND REPLACED WITH A LARGER 31MM WATCHMAN FLX PRO DEVICE. THE 31MM WDS MET POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA AND THE 31MM CLOSURE DEVICE RELEASED. A PERICARDIAL EFFUSION SWEEP WAS PERFORMED BEFORE THE PROCEDURE, SEVERAL TIMES DURING AND AFTER IMPLANT PROCEDURE WITH NO FINDINGS. IT WAS REPORTED THAT AFTER THE PATIENT WAS RETURNED TO POST-OP CARE AREA, THE PATIENT BLOOD PRESSURE WAS OBSERVED TO BE NOTABLY LOWER. THE ANESTHESIOLOGIST PERFORMED A LIMITED ECHO AND NO PERICARDIAL EFFUSION WAS SEEN. PER THE ANESTHESIOLOGIST, ALBUMIN AND FLUID

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22798357 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT FOR LAAC WAS SELECTED FOR USE. THE PHYSICIAN GAVE HEPARIN AS SOON AS TRANSSEPTAL PUNCTURE WAS COMPLETED WITH THE VERSACROSS CONNECT AND WATCHMAN FXD DOUBLE CURVE. THERE WAS NO CLOT SEEN ON FLUOROSCOPY OR TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS ADVANCED THROUGH WATCHMAN SHEATH, CONTRAST WAS INJECTED TO VISUALIZE THE APPENDAGE. ONCE ANGIOGRAM WAS COMPLETED, THE PIGTAIL CATHETER WAS REMOVED AND A CLOT WAS FOUND ON THE TIP. ACTIVATED CLOTTING TIME (ACT) WAS 246 AND AN ADDITIONAL 4000 UNITS OF HEPARIN WERE GIVEN. A SCAN WAS DONE WITH TEE AND NO CLOT FOUND IN THE APPENDAGE OR LEFT ATRIAL APPENDAGE (LAA). NOTHING WAS SEEN ON FLUOROSCOPY EITHER. THE WATCHMAN DEVICE WAS PREPPED AND DEPLOYED. DEVICE PASS CRITERIA WAS MET AND PHYSICIAN RELEASED THE DEVICE. AS THE PHYSICIAN CAME BACK TO THE RIGHT SIDE OF THE HEART A SMALL CLOT WAS SEEN ON THE SEPTUM ON THE RIGHT SIDE. PHYSICIAN DECIDED TO LEAVE IT AND DID NOT GIVE PROTAMINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER PATIENT COMPLICATIONS. THE PATIENT STABLE, AND WAS NOT HOSPITALIZED AND THEY WERE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22668165 ↗
• InjuryJul 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN AORTIC HEMATOMA AND PERFORATION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. TRANSSEPTAL POSITION WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND APPEARED TO BE MID/MID ON THE SEPTUM. THE VERSACROSS RADIO FREQUENCY (RF) WIRE WAS PLACED ON THE SEPTUM AND RF WAS APPLIED, BUT NOTHING WAS OBSERVED IN THE LEFT ATRIUM. A NEW POSITION WAS OBTAINED, AND RF WAS DELIVERED SUCCESSFULLY TO CROSS INTO THE LEFT ATRIUM. IMAGING WAS POOR QUALITY. NO DIFFICULT ANATOMY AND NO OTHER COMPLICATIONS. AFTER ATTEMPTING THE WIRE FURTHER INTO THE LEFT ATRIAL APPENDAGE (LAA), CHANGE IN AORTIC ROOT WAS OBSERVED BY TEE IMAGER. THE PROCEDURE WAS PAUSED FOR FURTHER EVALUATION AND MONITORING OF AORTIC HEMATOMA. THE PATIENTS' VITALS REMAINED STABLE THROUGHOUT. IT WAS IMPLANTING PROVIDERS DECISION TO ABORT PROCEDURE TO FURTHER MONITOR PATIENT AND GET CARDIAC COMPUTED TOMOGRAPHY (CT) FOR FURTHER DIAGNOSIS. DURING CASE DEBRIEF, CASE IMAGING WAS REVIEWED AND APPEARED TO SHOW THE FIRST TRANSSEPTAL ATTEMPT CROSSED INTO THE AORTA. THE PATIENT WAS SENT TO INTENSIVE CARE UNIT FOR OVERNIGHT MON

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 22667998 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS WAS NOTED. DURING AN ATRIAL FIBRILLATION (AF) ABLATION WITH WATCHMAN IMPLANT, A VERSACROSS CONNECT FOR FARADRIVE WAS SELECTED FOR USE. THE PATIENT HAD PACEMAKER LEADS. THE PATIENT HAD BEEN FULLY HEPARINIZED PRIOR TO TRANSSEPTAL CROSSING. ACT READING WAS 354. THE TRANSSEPTAL PUNCTURE (TSP) WAS SUCCESSFUL AND WHEN ADVANCING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER OVER TO THE LEFT ATRIUM (LA), A CLOT WAS NOTED TO BE IN LA HUGGING AORTA. THE PHYSICIAN TRIED TO BRING FARADRIVE SHEATH CLOSER TO CLOT AND ASPIRATE BUT IT WOULD NOT MOVE. AT THE TIME IT WAS A NON-MOBILE STRUCTURE, AND THE PHYSICIAN WAS UNSURE OF WHAT THIS FOREIGN OBJECT. THE PHYSICIAN REMOVED EVERYTHING FROM LA AND CALLED FOR TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) TO GET A CLOSER LOOK AT THE OBJECT AND ADDITIONAL PHYSICIANS TO COME FOR A SECOND OPINION. WHEN PERFORMING TEE, THE STRUCTURE MOVED OVER TO THE LEFT ATRIAL APPENDAGE (LAA). AT THIS POINT, THE PHYSICIANS DETERMINED IT WAS LIKELY A CLOT THAT THE FARADRIVE SHEATH MAY HAVE GRABBED OFF ONE OF THE PACEMAKER LEADING ON RIGHT SIDE AND WAS BROUGHT OVER TO LA. THE DECISION WAS MADE BY THE PHYSICIANS TO ABORT AF ABLATION PORTION OF PROCEDURE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22543577 ↗
• InjuryJul 7, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED A CARDIAC TAMPONADE AND PERICARDIAL EFFUSION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. PRE-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IDENTIFIED A SMALL PERICARDIAL EFFUSION PRESENT AT BASELINE. THE VERSACROSS CONNECT SYSTEM WAS INTRODUCED THROUGH THE WATCHMAN SHEATH TO PERFORM THE TRANSSEPTAL PUNCTURE (TSP). THE DEVICE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) AND MANEUVERED DOWN TO THE INTERATRIAL SEPTUM UNDER TEE GUIDANCE. THE SEPTUM WAS NOTED TO BE HIGHLY ANEURYSMAL WITH A SMALL RIGHT ATRIUM TO MANEUVER IN, MAKING VISUALIZATION OF TENTING DIFFICULT. THE PHYSICIAN MANIPULATED THE WAS SHEATH TO LOCATE TENTING WITHOUT EXPOSING THE PIGTAIL WIRE. FOLLOWING THE TSP, THE IMAGER MONITORED FOR CHANGES IN THE PERICARDIAL EFFUSION WHILE THE PIGTAIL CATHETER WAS INSERTED. AN INCREASE IN THE SIZE OF THE EFFUSION WAS OBSERVED (BILATERAL). SUBSEQUENTLY, THE PATIENT DEVELOPED ATRIAL FIBRILLATION ALONG WITH HYPOTENSION. CARDIOVERSION WAS PERFORMED, AND THE EFFUSION WAS MONITORED. AN LAA ANGIOGRAM WAS CONDUCTED, CONFIRMING NO CONTRAST LEAKAGE FROM THE APPENDAGE INTO T

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

  MAUDE report 22415579 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A THROMBUS WAS NOTED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. NO THROMBUS NOTED PRIOR TO INSERTION OF RF WIRE. THE VERSACROSS RF WIRE WAS ADVANCED IN THE RIGHT ATRIUM. A THROMBUS WAS NOTED ON THE RF WIRE ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WHEN RIGHT SIDED BEFORE TRANSSEPTAL. THE THROMBUS WAS ASPIRATED OUT OF BODY, VISUALIZED ON CLOTH OF BACK TABLE AND IT WAS CONFIRMED IT IS NO LONGER SEEN ON TEE. THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER COMPLICATION ALONG WITH SAME RF WIRE AFTER ASPIRATING THROMBUS FROM WIRE, AND PATIENT REMAINED STABLE. NO DAMAGE NOTED. HEPARIN WAS ADMINISTERED BEFORE TSP. THEY WERE DISCHARGED AS EXPECTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22415573 ↗
• MalfunctionJun 11, 2025Use of Device Problem; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; Mechanics Altered; Use of Device Problem; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; Mechanics Altered

  IT WAS REPORTED THAT DURING A FARAPULSE PULMONARY VEIN ISOLATION PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN ADVANCED THE VERSACROSS RF WIRE TO SUPERIOR VENA CAVA (SVC) FOR TRANSSEPTAL, HOWEVER WAS UNABLE TO CROSS SEPTUM. WHEN THE WIRE WAS REMOVED FROM BODY, THE PIGTAIL WAS NOTED TO BE OUT OF PLANE AND MISSHAPEN, NOT HOLDING APPROPRIATE PIGTAIL CURVE, APPEARED STRETCHED. THUS, A NEW WIRE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE WIRE WAS INSERTED THROUGH NON-BOSTON SCIENTIFIC GUIDEWIRE LUMEN FROM STORAGE HOOP WITHOUT ISSUE AND RETRACTED COMPLETELY INSIDE CATHETER. DEVICE WAS PINCHED AND INSERTED INTO VALVE, WITH MANUAL INSERTION, THE PHYSICIAN FELT THE CATHETER BEND TO ONE DIRECTION, AND DID NOT ADVANCE STRAIGHT INTO SHEATH. PHYSICIAN FELT THIS WAS THE POINT THE KINK WAS CREATED IN BOTH THE CATHETER AND WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187393 ↗
• MalfunctionJun 11, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE TO TREAT ATRIAL FIBRILLATION/STROKE PREVENTION, VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT THE DILATOR TIP IS DAMAGED, SEEMED LIKE A TEAR. HENCE, THE DEVICE WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER VERSACROSS KIT. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187390 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN COMPLETED TRANSSEPTAL PUNCTURE AND ONCE GETTING TO LEFT ATRIUM, IT WAS NOTED A GROWING EFFUSION. THE PROCEDURE WAS STOPPED PROCEDURE TO ADDRESS EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND ABOUT 1000CC OF BLOOD WAS REMOVED BUT PUMPED BACK INTO PATIENT GRADUALLY. A BLEEDING WAS ALSO REPORTED. THE PATIENT WAS EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 22170068 ↗
• InjuryJun 9, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED A PERFORATION, PERICARDIAL EFFUSION (PE) LEADING TO CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TO GO TRANSEPTAL, ADVANCING THE WIRE MULTIPLE TIMES. WHEN WATCHING ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THERE WAS VISIBLE TENTING AND RADIO FREQUENCY WAS ADMINISTERED. THE WIRE DID NOT CROSS INTO THE LEFT ATRIUM SO ANOTHER ATTEMPT WAS MADE. THE SEPTUM WAS SLIPPERY CAUSING DIFFICULTY STAYING PUT ON THE SEPTUM. THE PROCEDURE CONTINUED ON TRYING TO CANNULATE THE APPENDAGE WHEN AN EFFUSION WAS DISCOVERED. THE EFFUSION WAS MEASURING 2.5CM SURROUNDING THE HEART. A PERICARDIOCENTESIS BEGAN AND WHEN WIRE ACCESS WAS LOST DURING THAT TIME THE SURGEON WAS CALLED. PERICARDIAL WINDOW WAS STARTED AND GOT 300 ML OFF BEFORE BAG WAS ATTACHED. THE PATIENTS CHEST WAS THEN CRACKED OPEN ON THE TABLE. THE APPENDAGE WAS CLIPPED. THE PATIENT REMAINS STABLE AND HAS THROUGHOUT THE ENTIRE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER CONFIRMED THE PATIENT DID WELL AFTER AND POSSIBLY BEING DISCHARGED. THERE WAS TENTING AND THE DIFFIC

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 22170067 ↗
• InjuryJun 5, 2025Display or Visual Feedback Problem; Device Sensing Problem; Display or Visual Feedback Problem; Device Sensing Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. A TRACE EFFUSION WAS NOTED AT THE START OF THE CASE. WHILE TRYING TO GO TRANSEPTAL WHICH APPEARED TO BE AT MID/MID ON THE SEPTUM. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING WAS VERY DIFFICULT TO GO OFF OF. WHEN BUZZED ACROSS THERE WERE NO BUBBLES IN THE LEFT ATRIUM AND THE WIRE WAS NOT SEEN IN THE LEFT ATRIUM. A PERICARDIAL EFFUSION CHECK ON TEE WAS PERFORMED, AND AT THAT TIME THE ECHO CARDIOLOGIST NOTICED THE EFFUSION WENT FROM TRACE TO SMALL. PRESSURES REMAINED STABLE BUT THERE WAS A CHANGE IN THE SIZE OF THE EFFUSION. PROTAMINE WAS GIVEN AND CONTINUED MONITORING THE PATIENT. ABOUT TEN MINUTES LATER THE PRESSURES SLIGHTLY DROPPED AND THE EFFUSION HAD GOTTEN A LITTLE LARGER. A PERICARDIOCENTESIS WAS PERFORMED AND 200CC OF BLOOD WAS REMOVED. PATIENT IS CURRENTLY STABLE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22153657 ↗
• InjuryJun 2, 2025Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED A PERFORATION, PERICARDIAL EFFUSION (PE) LEADING TO CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TO GO TRANSEPTAL, ADVANCING THE WIRE MULTIPLE TIMES. WHEN WATCHING ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THERE WAS VISIBLE TENTING AND RADIO FREQUENCY WAS ADMINISTERED. THE WIRE DID NOT CROSS INTO THE LEFT ATRIUM SO ANOTHER ATTEMPT WAS MADE. THE SEPTUM WAS SLIPPERY CAUSING DIFFICULTY STAYING PUT ON THE SEPTUM. THE PROCEDURE CONTINUED ON TRYING TO CANNULATE THE APPENDAGE WHEN AN EFFUSION WAS DISCOVERED. THE EFFUSION WAS MEASURING 2.5CM SURROUNDING THE HEART. A PERICARDIOCENTESIS BEGAN AND WHEN WIRE ACCESS WAS LOST DURING THAT TIME THE SURGEON WAS CALLED. PERICARDIAL WINDOW WAS STARTED AND GOT 300 ML OFF BEFORE BAG WAS ATTACHED. THE PATIENTS CHEST WAS THEN CRACKED OPEN ON THE TABLE. THE APPENDAGE WAS CLIPPED. THE PATIENT REMAINS STABLE AND HAS THROUGHOUT THE ENTIRE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 22127172 ↗
• MalfunctionJun 2, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE WIRE WAS FRAYED. THE WIRE AS ALSO REPORTED KINKED. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125596 ↗
• InjuryMay 27, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. PRE-IMAGING SHOWED TRACE EFFUSION PRIOR TO PROCEDURE. THE PHYSICIAN OBTAINED GROIN ACCESS AND THE FIRST VERSACROSS CONNECT SYSTEM WAS INSERTED UP TO SUPERIOR VENA CAVA (SVC). THE PHYSICIAN COMPLAINED OF DIFFICULTIES RETRACTING THE RF WIRE FROM THE DILATOR, THUS BOTH THE WIRE AND DILATOR WERE REMOVED AND REPLACED WITH A NEW A VERSACROSS CONNECT SYSTEM. THE PHYSICIAN WENT UP TO THE SVC WITH THE WIRE SEVERAL TIMES AND ATTEMPTED TO DROP DOWN TO THE FOSSA GETTING INFERIOR ON THE SEPTUM. THE SEPTUM WAS VERY ANEURYSMAL AND EACH TIME THE PHYSICIAN DROPPED DOWN TO THE INFERIOR VENA CAVA (IVC), THE VERSACROSS SYSTEM FELL OFF AND REWIRE WAS DONE AGAIN TO GET TO THE SVC. AFTER SEVERAL RESHAPING OF THE VERSACROSS CONNECT AND ADVANCEMENT TO THE SVC AND FALLING OFF INFERIOR, THE PATIENT STARTED TO DEVELOP A LARGER CIRCUMFERENTIAL EFFUSION AT 1.07 CENTIMETERS. THE PHYSICIAN DECIDED TO INTERVENE BY PERFORMING A PERICARDIAL TAP AND REMOVED 500CC OF FLUID OFF THE PERICARDIUM. THE PATIENT REMAINED HEMODY

  Patient problems: Pericardial Effusion

  MAUDE report 22088829 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WENT IN HEART BLOCK. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE IMPLANTING PHYSICIAN OBTAINED ACCESS IN THE LEFT FEMORAL VEIN AND BEGAN INTRODUCING THE VERSACROSS RF PIGTAIL WIRE THROUGH A 16FR SHEATH. THEN, THE PHYSICIAN FOLLOWED THE WIRE WITH THE WATCHMAN DOUBLE CURVE SHEATH AND THE VERSACROSS CONNECT DILATOR. WHILE DROPPING DOWN FROM THE SUPERIOR VENA CAVA (SVC) INTO THE RIGHT ATRIUM, THE PATIENT WENT ASYSTOLIC. CHEST COMPRESSIONS WERE DONE AND PATIENT RHYTHM RETURNED AFTER THREE MINUTES. THE PATIENT WAS IN HEART BLOCK AND RECEIVED A TEMPORARY TRANSVENOUS PACING WIRE. THE PATIENT WAS HOSPITALIZED AND LATER HAS BEEN DISCHARGED, EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THERE WERE NO ISSUES NOTED WITH TRANSSEPTAL. THE PATIENT'S EKG PRIOR TO IMPLANT DAY SUGGESTS THAT THE HAD SOME CONDUCTION ISSUES (WIDE QRS).

  Patient problems: Asystole; Heart Block

  MAUDE report 22055365 ↗
• MalfunctionMay 20, 2025Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS UNABLE TO INSERT THE RF WIRE THROUGH THE DILATOR AND FELT A SHARP EDGE ON THE WIRE THAT PREVENTED FROM INSERTING IT. RESISTANCE WHEN LOADING CABLE THROUGH THE DILATOR. DOCTOR EXPRESSED THAT HE FELT RESISTANCE BECAUSE HE HAD POROSITY AND AN ADDITIONAL SHARP TEXTURE IN THE WIRE.THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055359 ↗
• InjuryMay 9, 2025Display or Visual Feedback Problem; Difficult to Advance; Display or Visual Feedback Problem; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PATIENT ANATOMY WAS CHALLENGING TO VISUALIZE ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DUE TO THE PATIENT HAVING A SEPTAL OCCLUDER. THE PHYSICIAN WAS MADE AWARE THAT THIS WAS A CONTRAINDICATION OF THE PROCEDURE AND THE DECISION WAS MADE TO PROCEED. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS INSERTED TO OBTAIN OTHER VIEWS OF THE SEPTUM. THE ANATOMY WAS CHALLENGING TO SEE BUT VIEWS OF THE INFERIOR/SUPERIOR PORTION WAS VISUALIZED. THE TRANSSEPTAL PUNCTURE WAS ATTEMPTED BUT FELT RESISTANCE UPON ADVANCEMENT OF THE PIGTAIL WIRE. IT WAS UNABLE TO VISUALIZE THE WIRE IN THE LEFT ATRIUM, THE PHYSICIAN REMOVED THE WIRE BACK INTO THE TRUSTEER AND VERSACROSS CONNECT DILATOR. THE PHYSICIANS CHECKED FOR EFFUSION BEFORE CONTINUING AND FOUND A SMALL COLLECTION OF FLUID 'ON THE POSTERIOR PORTION OF THE HEART' WHICH 'APPEARED TO LOCULATED AND LOCALIZED'. THE PATIENT WAS MONITORED FOR SEVERAL MINUTES WHILE CV SURGERY WAS CONSULTED. THE DECISION WAS MADE TO ADMIT THE PATIENT AND MONITOR OVER NIGHT AS SHE WAS STABLE AND HAD NOT HAD ANY HE

  Patient problems: Pericardial Effusion

  MAUDE report 21998600 ↗
• MalfunctionMay 9, 2025Thermal Decomposition of Device; Failure to Advance; Thermal Decomposition of Device; Failure to Advance

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR LEFT ATRIAL APPENDAGE CLOSURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CROSS THE SEPTUM WITH RF WIRE FOUR DIFFERENT TIMES, BUT THE RF WIRE WAS NOT ABLE TO CROSS AND NO ERROR CODE WAS NOTED ON THE GENERATOR. POSITION OF THE RF WIRE WAS ALSO VERIFIED; THE SEPTUM WAS THIN AND HAD A NICE CONTACT. THUS, THE RF WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS. THE RF WAS APPLIED ALL FOUR TIMES AND THE RF WIRE WAS 1-3 MM TENT PRIOR TO THE CROSSING. ADDITIONALLY, IT WAS ALSO MENTIONED THAT PIGTAIL WIRE LOOKED NORMAL IN SHAPE, BUT THE TIP OF THE WIRE WAS BLACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996801 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA AND SMALL EFFUSION. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE VERSACROSS CONNECT WAS IN THE BODY, ATTEMPTING FOR TRANSSEPTAL PUNCTURE USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE RADIO FREQUENCY WAS NOT USED, WHEN THE PATIENT'S BLOOD PRESSURE DROPPED, RHYTHM CHANGED, AND A SMALL EFFUSION NOTED. THE PATIENT WAS TREATED WITH MEDICATIONS AND THE PHYSICIAN DECIDED NOT TO PROCEED WITH WATCHMAN PROCEDURE AT THIS TIME. THE PATIENT WAS ADMITTED FOR OBSERVATION AND IS EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 21987183 ↗
• InjuryMay 7, 2025Display or Visual Feedback Problem; Device Sensing Problem; Positioning Problem; Display or Visual Feedback Problem; Device Sensing Problem; Positioning Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN GAINED ACCESS TO VEIN AND THEN ADVANCED THE WIRE UP TO THE SUPERIOR VENA CAVA (SVC). THE SHEATH WAS THEN ADVANCED UP TO THE SVC. THEN, THE PHYSICIAN DROPPED DOWN ON TO THE FOSSA, HOWEVER THE TENTING WAS NOT SEEN. THE PHYSICIAN ADVANCED THE WIRE UP TO THE SVC HOWEVER IT WAS NOTED THEY WERE INFERIOR AND MID ON SHORT AXIS BUT IT WAS SUSPECTED THAT THEY WERE TOO INFERIOR AND THE RF WIRE WENT THROUGH THE RIGHT ATRIUM. THE PATIENT PRESSURE DROPPED AND AROUND A CENTIMETER EFFUSION NOTED. A 400 CC BLOOD WAS ASPIRATED AND THEN INFUSED BACK IN. THE PATIENT WAS STABLE AND HENCE THE PHYSICIAN PROCEEDED WITH A 35 MM WATCHMAN DEVICE WAS RELEASED. THERE WAS NO EFFUSION AT END OF PROCEDURE. ECHO WAS REPEATED AND NO EFFUSION WAS SEEN. THE PATIENT WAS EXPECTED TO FULLY RECOVER, STAYED ONE DAY AT THE HOSPITAL AND HAS BEEN DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). DIFFICULT ANATOMY HEART ROTATED WAS REPORTED. IT WAS NOT POSSIBLE TO SEE THE TENT WELL ON TEE IN 90 VIEW WHICH SHOWS IVC SVC. DRAINED THE FLUID ONCE BLO

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

  MAUDE report 21977557 ↗
• MalfunctionMay 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR WATCHMAN PROCEDURE. DURING THE PROCEDURE IT WAS MENTIONED THAT WHEN ATTEMPT WAS MADE TO INSERT THE WIRE INTO THE VERSACROSS DILATOR, THE INSULATION OF THE PROXIMAL END OF THE WIRE WAS NOTED BROKEN AND BUCKLED. THEREFORE, IT WAS NOT POSSIBLE TO INSERT THE WIRE INTO THE DILATOR. THUS, THE WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961222 ↗
• InjuryApr 23, 2025Difficult to Advance; Material Deformation; Material Integrity Problem; Positioning Problem; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Material Integrity Problem; Positioning Problem; Physical Resistance/Sticking

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THERE WAS A TRIVIAL PE NOTED WHEN SWEEPING FOR PRE-EXISTING PE PRIOR TO IMPLANTATION. THE PHYSICIAN OBTAINED RIGHT FEMORAL VEIN ACCESS AND AN 8 FR SHEATH, AND THE VERSACROSS PIGTAIL RF WIRE WAS INSERTED AND ADVANCED TO THE SUPERIOR VENA CAVA (SVC). THE 8 FR SHEATH WAS EXCHANGED OVER THE WIRE FOR A WATCHMAN FXD DOUBLE CURVE SHEATH (WAS). WHILE ADVANCING WAS OVER THE WIRE TO THE SVC, DIFFICULTY WAS ENCOUNTERED DUE TO THE POSTERIOR AND LATERAL ORIENTATION OF THE SVC IN RELATION TO THE INFERIOR VENA CAVA (IVC) AND RIGHT ATRIUM. THE WIRE MADE A MODERATE TURN INTO THE SVC, ALLOWING THE WAS TO ENTER THE RIGHT ATRIUM INSTEAD OF TRACKING THE WIRE INTO THE SVC. THE WIRE WAS KINKED AT AN ANGLE OF 35 TO 45 DEGREES. THIS KINK MADE IT DIFFICULT TO ADVANCE THE WAS OVER THE WIRE. THE WIRE WAS WITHDRAWN INTO THE DILATOR, THE DROP DOWN TO THE FOSSA WAS PERFORMED, ONCE POSITION WAS OBTAINED FOR TRANSSEPTAL PUNCTURE, AN ATTEMPT TO ADVANCE THE WIRE WAS MADE. THE PHYSICIAN HAVING DIFFICULTY ADVANCING THE WIRE, CLOCKED THE SHEATH OFF

  Patient problems: Pericardial Effusion

  MAUDE report 21892243 ↗
• InjuryApr 23, 2025Adverse 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 LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. THERE WAS A TRIVIAL PE NOTED WHEN SWEEPING FOR PRE-EXISTING PE PRIOR TO IMPLANTATION. THE PHYSICIAN OBTAINED RIGHT FEMORAL VEIN ACCESS AND AN 8 FR SHEATH, AND THE VERSACROSS PIGTAIL RF WIRE WAS INSERTED AND ADVANCED TO THE SUPERIOR VENA CAVA (SVC). THE 8 FR SHEATH WAS EXCHANGED OVER THE WIRE FOR A WATCHMAN FXD DOUBLE CURVE SHEATH (WAS). WHILE ADVANCING WAS OVER THE WIRE TO THE SVC, DIFFICULTY WAS ENCOUNTERED DUE TO THE POSTERIOR AND LATERAL ORIENTATION OF THE SVC IN RELATION TO THE INFERIOR VENA CAVA (IVC) AND RIGHT ATRIUM. THE WIRE MADE A MODERATE TURN INTO THE SVC, ALLOWING THE WAS TO ENTER THE RIGHT ATRIUM INSTEAD OF TRACKING THE WIRE INTO THE SVC. THE WIRE WAS KINKED AT AN ANGLE OF 35 TO 45 DEGREES. THIS KINK MADE IT DIFFICULT TO ADVANCE THE WAS OVER THE WIRE. THE WIRE WAS WITHDRAWN INTO THE DILATOR, THE DROP DOWN TO THE FOSSA WAS PERFORMED, ONCE POSITION WAS OBTAINED FOR TRANSSEPTAL PUNCTURE, AN ATTEMPT TO ADVANCE THE WIRE WAS MADE. THE PHYSICIAN HAVING DIFFICULTY ADVANCING THE WIRE, CLOCKED THE SHEATH OFF

  Patient problems: Pericardial Effusion

  MAUDE report 21892241 ↗