VersaCross Connect LAAC Access Solution VXAK0001 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00685447012566), received between Apr 25, 2023 and Jul 31, 2024 — classified as 2 deaths, 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2024Display or Visual Feedback Problem; Material Deformation; Positioning Problem; Display or Visual Feedback Problem; Material Deformation; Positioning Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED; THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. THE PATIENT WAS INTUBATED BY GENERAL ANESTHESIA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED PRIOR TO THE PROCEDURE AND A SMALL PLEURAL EFFUSION WAS NOTED AT RIGHT VENTRICLE. THE GROIN ACCESS WAS OBTAINED AND THE VERSACROSS RF WIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) TOWARDS THE SEPTUM. FOLLOWING (B)(4) UNSUCCESSFUL ATTEMPTS TO OBTAIN AN APPROPRIATE LOCATION AND VISUALIZATION ON THE SEPTUM, AN EFFUSION WAS NOTED ON TEE AROUND THE RIGHT ATRIUM (RT). AT THIS POINT, THE PHYSICIAN STOPPED THE PROCEDURE, REVERSED HEPARIN WAS GIVEN, AND MONITORED THE EFFUSION, WHICH WAS DEEMED STABLE SHORTLY AFTER, AS WELL AS THE PATIENT. THE PATIENT WAS THEN ADMITTED FOR OVERNIGHT OBSERVATION FOR A FOLLOW-UP ECHOCARDIOGRAM. THE FOLLOW-UP PERFORMED NEXT DAY SHOWED MINIMAL EFFUSION AND THE PATIENT WAS DISCHARGED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). THE SMALL PLEURAL EFFUSION AROUND THE RIGHT VENTRICLE NOTED PRIOR TO THE PROCEDURE REMAINED UNCHANGED IN SIZE WHEN

  Patient problems: Pericardial Effusion

  MAUDE report 19874761 ↗
• InjuryJul 31, 2024Positioning Problem; Positioning Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED, THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. THE PATIENT WAS INTUBATED BY GENERAL ANESTHESIA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED PRIOR TO THE PROCEDURE AND A SMALL PLEURAL EFFUSION WAS NOTED AT RIGHT VENTRICLE. THE GROIN ACCESS WAS OBTAINED AND THE VERSACROSS RF WIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) TOWARDS THE SEPTUM. FOLLOWING THREE UNSUCCESSFUL ATTEMPTS TO OBTAIN AN APPROPRIATE LOCATION AND VISUALIZATION ON THE SEPTUM, AN EFFUSION WAS NOTED ON TEE AROUND THE RIGHT ATRIUM (RT). AT THIS POINT, THE PHYSICIAN STOPPED THE PROCEDURE, REVERSED HEPARIN WAS GIVEN, AND MONITORED THE EFFUSION, WHICH WAS DEEMED STABLE SHORTLY AFTER, AS WELL AS THE PATIENT. THE PATIENT WAS THEN ADMITTED FOR OVERNIGHT OBSERVATION FOR A FOLLOW-UP ECHOCARDIOGRAM. THE FOLLOW-UP PERFORMED NEXT DAY SHOWED MINIMAL EFFUSION AND THE PATIENT WAS DISCHARGED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). THE SMALL PLEURAL EFFUSION AROUND THE RIGHT VENTRICLE NOTED PRIOR TO THE PROCEDURE REMAINED UNCHANGED IN SIZE WHEN T

  Patient problems: Pericardial Effusion

  MAUDE report 19874756 ↗
• DeathJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT THE PATIENT WENT INTO FLASH PULMONARY EDEMA AND PASSED AWAY, PROCEDURE CANCELLED. A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR DURING A WATCHMAN (LEFT ATRIAL APPENDAGE CLOSURE) CASE. THE PATIENT WAS INTUBATED, AND THE PROCEDURE STARTED. WHILE ATTEMPTING TO GO TRANSSEPTAL ON A DIFFICULT ANATOMY, THE ANESTHESIA PHYSICIAN STARTED SUCTIONING OUT FOAMY BLOOD FROM THE INTUBATION TUBE. AFTER SOME TIME HAD PASSED, THE ANESTHESIA PHYSICIAN COMMENT THAT THE PATIENT WAS UNSTABLE, AND THE PROCEDURE WAS ABORTED. THE PATIENT WENT INTO FLASH PULMONARY EDEMA BEFORE CROSSING THE INTERATRIAL SEPTUM. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), HOWEVER PASSED AWAY AROUND 10:30PM THAT NIGHT. THE PHYSICIAN DID NOT SUSPECT THAT THE DEVICES THEMSELVES CAUSED OR CONTRIBUTED TO THE PATIENT DEATH, AND IT WAS NOT BASED ON A PROCEDURE COMPLICATION. AN OFFICIAL CAUSE OF DEATH WAS NOT PROVIDED. NO SURGICAL INTERVENTION WAS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). IT WAS FURTHER REPORTED THAT THE ISSUE WAS NOTED WHILE THEY WERE ATTEMPTING TO GO TRANSSEPTAL. THE WATCHMAN SHEATH AND THE VERSACROSS CONNECT SYSTEM WERE I

  Patient problems: Pulmonary Edema

  MAUDE report 19601123 ↗
• DeathJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT THE PATIENT WENT INTO FLASH PULMONARY EDEMA AND PASSED AWAY, PROCEDURE CANCELLED. A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR DURING A WATCHMAN (LEFT ATRIAL APPENDAGE CLOSURE) CASE. THE PATIENT WAS INTUBATED, AND THE PROCEDURE STARTED. WHILE ATTEMPTING TO GO TRANSSEPTAL ON A DIFFICULT ANATOMY, THE ANESTHESIA PHYSICIAN STARTED SUCTIONING OUT FOAMY BLOOD FROM THE INTUBATION TUBE. AFTER SOME TIME HAD PASSED, THE ANESTHESIA PHYSICIAN COMMENT THAT THE PATIENT WAS UNSTABLE, AND THE PROCEDURE WAS ABORTED. THE PATIENT WENT INTO FLASH PULMONARY EDEMA BEFORE CROSSING THE INTERATRIAL SEPTUM. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), HOWEVER PASSED AWAY AROUND 10:30PM THAT NIGHT. THE PHYSICIAN DID NOT SUSPECT THAT THE DEVICES THEMSELF CAUSED OR CONTRIBUTED TO THE PATIENT DEATH, AND IT WAS NOT BASED ON A PROCEDURE COMPLICATION. AN OFFICIAL CAUSE OF DEATH WAS NOT PROVIDED. NO SURGICAL INTERVENTION WAS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: Pulmonary Edema

  MAUDE report 19467714 ↗
• InjuryMay 7, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. ON THE FIRST AND SECOND TRANSSEPTAL PUNCTURE (TSP) ATTEMPT, BUBBLES COULD BE SEEN IN THE LEFT ATRIUM, HOWEVER THE DEVICES WERE UNABLE TO ADVANCE ACROSS THE SEPTUM. ON THE THIRD ATTEMPT, THE PHYSICIAN WAS ABLE TO CROSS THE SEPTUM ALONG WITH THE VERSACROSS CONNECT, WATCHMAN SHEATH AND AN INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETERS. AS THE ICE CATHETER WAS IN THE LEFT ATRIUM, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND A 1-2CM PE WAS IDENTIFIED PREDOMINATELY AROUND THE RIGHT VENTRICLE, THOUGH IT WAS FOUND CIRCUMFERENTIAL. THUS, PROTAMINE WAS QUICKLY GIVEN AND A PERICARDIOCENTESIS WAS PERFORMED WITH 475ML OF BLOOD DRAINED. ALSO, MEDICATIONS WERE GIVEN TO STABILIZE THE BLOOD PRESSURE. THE PE HAD RESOLVED, THE BLOOD PRESSURE STABILIZED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT MONITORING. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PATIENT WAS NOT UNDER WARFARIN NOT ANTIPLATELET DRUGS AT THE TIME. IT WAS FURTHER CONFIRMED THAT THE PATIENT HAD DIFFICULT ANATOMY,

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19259558 ↗
• InjuryMay 7, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. ON THE FIRST AND SECOND TRANSSEPTAL PUNCTURE (TSP) ATTEMPT, BUBBLES COULD BE SEEN IN THE LEFT ATRIUM, HOWEVER THE DEVICES WERE UNABLE TO ADVANCE ACROSS THE SEPTUM. ON THE THIRD ATTEMPT, THE PHYSICIAN WAS ABLE TO CROSS THE SEPTUM ALONG WITH THE VERSACROSS CONNECT, WATCHMAN SHEATH AND AN INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETERS. AS THE ICE CATHETER WAS IN THE LEFT ATRIUM, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND A 1-2CM PE WAS IDENTIFIED PREDOMINATELY AROUND THE RIGHT VENTRICLE, THOUGH IT WAS FOUND CIRCUMFERENTIAL. THUS, PROTAMINE WAS QUICKLY GIVEN AND A PERICARDIOCENTESIS WAS PERFORMED WITH 475ML OF BLOOD DRAINED. ALSO, MEDICATIONS WERE GIVEN TO STABILIZE THE BLOOD PRESSURE. THE PE HAD RESOLVED, THE BLOOD PRESSURE STABILIZED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT MONITORING. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PATIENT WAS NOT UNDER WARFARIN NOT ANTIPLATELET DRUGS AT THE TIME. IT WAS FURTHER CONFIRMED THAT THE PATIENT HAD DIFFICULT ANATOMY,

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19259553 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY AND THE SHEATH WAS ADVANCED ACROSS THE SEPTUM. THE VERSACROSS DILATOR WAS REMOVED AND PIGTAIL WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE (LAA). AT THAT TIME THE ANESTHESIOLOGIST NOTED A DROP IN PATIENTS' BLOOD PRESSURE AND AN EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A CENTRAL LINE WAS PLACED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABILIZED, WAS TRANSFERRED FOR FURTHER OBSERVATION AND REMAINS IN THE HOSPITAL, EXPECTED TO FULLY RECOVER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PHYSICIAN BELIEVES THE EFFUSION OCCURRED EITHER DURING CROSSING OF SEPTUM OR POST TSP, AFTER THE PIGTAIL INSERTED INTO LAA. NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME OF EVENT, BUT IT WAS UNDER PRADAXA. IT WAS LATER CONFIRMED THAT THE PHYSICIAN DOES NOT FEEL THE EQUIPMENT CAUSED THE EVENT. WHEN RADIO FREQUENCY WAS APPLIED, THE TEE PHYSICIAN COULD NOT F

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

  MAUDE report 19216370 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE), PERFORATION, HEMATOMA AND CARDIAC TAMPONADE OCCURRED. DURING WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE, A VERSACROSS CONNECT WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED AND THE WATCHMAN CLOSURE DEVICE WAS IMPLANTED. A PERICARDIAL EFFUSION WAS NOTED BY THE ECHO PHYSICIAN. A PERICARDIOCENTESIS WAS PERFORMED HOWEVER THE BLEEDING DID NOT STOP. THE PATIENT WAS TRANSFERRED TO SURGERY WHERE A SMALL PERFORATION WAS IDENTIFIED IN THE DESCENDING AORTA AND WAS REPAIRED. THE PHYSICIAN SUSPECTED THAT THE PERFORATION MAY HAVE OCCURRED DURING TSP. THE PATIENT WAS ADMITTED TO THE SURGICAL INTENSIVE CARE UNIT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED THE PE WAS FIRST NOTICED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PHYSICIAN DURING THE DEVICE DEPLOYMENT. THERE WAS NO DIFFICULTY NOTED WITH PATIENT ANATOMY, OR REQUIRED MULTIPLE ATTEMPTS TO TRACK UP / DROP DOWN INTO POSITION ON SEPTUM. THERE WAS NO IMAGING/VISUALIZATION ISSUES. PER PHYSICIAN THERE WAS NO ISSUES NOTED WITH THE TSP OR ANY OF THE VERSACROSS DEVICES.

  Patient problems: Cardiac Tamponade; Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels; Pericardial Effusion

  MAUDE report 18810646 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. A PERFORATION AND A PERICARDIAL EFFUSION WERE NOTED. THE PROCEDURE WAS CANCELLED. THE PHYSICIAN NOTED THAT THERE WAS A SMALL POSTERIOR LOCALIZED PERICARDIAL EFFUSION OBSERVED VIA INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) PRIOR TO PROCEDURE. THERE WASN'T ANY DIFFICULTY IN CROSSING THE SEPTUM. THE WATCHMAN WAS ADVANCED INTO THE LEFT ATRIUM APPENDAGE AFTER TRANSEPTAL PUNCTURE. DURING THE CONTRAST INJECTION OF APPENDAGE, THE PHYSICIAN NOTED A PERFORATION OF THE LEFT ATRIAL APPENDAGE WITH A CIRCUMFERENTIAL PERICARDIAL EFFUSION. THE VERSACROSS RF WIRE WAS STILL IN THE LEFT ATRIUM WHEN THE PERFORMATION WAS NOTICED. THEN, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE EFFUSION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. THE PATIENT RECOVERED AND IT WAS DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS REPORTED THAT IT IS POSSIBLE THAT THE PERFORATION HAD HAPPENED ALONG WITH WATCHMAN DOUBLE CURVE SHEATH AND VERSACROSS CONNECT DILATOR. POSSIBLY HAPPENED AFTER REMOVAL OF DILATOR AND POSITIONING OF SHEATH INTO AP

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18660042 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. A PERFORATION, A PERICARDIAL EFFUSION AND A CARDIAC TAMPONADE WERE REPORTED. THE PROCEDURE WAS CANCELLED. WHILE USING VERSACROSS CONNECT, THE PHYSICIAN ENGAGED THE SEPTUM AND VISUALIZED ON BOTH FLUORO AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) (BICAVAL BIPLANE ANGLE). ONCE TENTING WAS CONFIRMED, THE RADIO FREQUENCY WAS GIVEN AND IT WAS CROSSED TO THE LEFT SIDE OF THE HEART. THE VERSACROSS RF WIRE WAS SEEN IN THE LAA (LEFT ATRIUM APPENDAGE), SO THE PHYSICIAN CLOCKED THE VERSACROSS RF WIRE TO TRY AND SIT IN A PULMONARY VEIN. THE PHYSICIAN THOUGHT HE WAS IN THE RIGHT PULMONARY VEIN AND STARTED PUSHING THE DILATOR AND SHEATH ACROSS. AT CERTAIN POINT, IT WAS NOT POSSIBLE TO VISUALIZE WHERE THE DILATOR/SHEATH OR VERSACROSS RF WIRE WAS ON ECHO (DUE TO THE PATIENT'S ANATOMY, AND TO TEE IMAGING ISSUES AND COMMUNICATION ISSUES BETWEEN THE IMPLANTER AND ECHOCARDIOGRAPHER). AFTER A COUPLE MINUTES OF TRYING TO FIND OUT WHERE THE SYSTEM WAS, THE ECHOCARDIOGRAPHER CHECKED FOR EFFUSION AND THE BASELINE PERICARDIAL EFFUSION WAS GETTING BIGGER. SOON AFTER, THE PATIENT'S BLOOD PRESSURE DROPPED, A

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

  MAUDE report 18660041 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. A PERFORATION, A PERICARDIAL EFFUSION AND A CARDIAC TAMPONADE WERE REPORTED. THE PROCEDURE WAS CANCELLED. WHILE USING VERSACROSS CONNECT, THE PHYSICIAN ENGAGED THE SEPTUM AND VISUALIZED ON BOTH FLUORO AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) (BICAVAL BIPLANE ANGLE). ONCE TENTING WAS CONFIRMED, THE RADIO FREQUENCY WAS GIVEN AND IT WAS CROSSED TO THE LEFT SIDE OF THE HEART. THE VERSACROSS RF WIRE WAS SEEN IN THE LAA (LEFT ATRIUM APPENDAGE), SO THE PHYSICIAN CLOCKED THE VERSACROSS RF WIRE TO TRY AND SIT IN A PULMONARY VEIN. THE PHYSICIAN THOUGHT HE WAS IN THE RIGHT PULMONARY VEIN AND STARTED PUSHING THE DILATOR AND SHEATH ACROSS. AT CERTAIN POINT, IT WAS NOT POSSIBLE TO VISUALIZE WHERE THE DILATOR/SHEATH OR VERSACROSS RF WIRE WAS ON ECHO (DUE TO THE PATIENT'S ANATOMY, AND TO TEE IMAGING ISSUES AND COMMUNICATION ISSUES BETWEEN THE IMPLANTER AND ECHOCARDIOGRAPHER). AFTER A COUPLE MINUTES OF TRYING TO FIND OUT WHERE THE SYSTEM WAS, THE ECHOCARDIOGRAPHER CHECKED FOR EFFUSION AND THE BASELINE PERICARDIAL EFFUSION WAS GETTING BIGGER. SOON AFTER, THE PATIENT'S BLOOD PRESSURE DROPPED, A

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

  MAUDE report 18660038 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. A PERFORATION AND A PERICARDIAL EFFUSION WERE NOTED. THE PROCEDURE WAS CANCELLED. THE PHYSICIAN NOTED THAT THERE WAS A SMALL POSTERIOR LOCALIZED PERICARDIAL EFFUSION OBSERVED VIA INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) PRIOR TO PROCEDURE. THERE WASN'T ANY DIFFICULTY IN CROSSING THE SEPTUM. THE WATCHMAN WAS ADVANCED INTO THE LEFT ATRIUM APPENDAGE AFTER TRANSEPTAL PUNCTURE. DURING THE CONTRAST INJECTION OF APPENDAGE, THE PHYSICIAN NOTED A PERFORATION OF THE LEFT ATRIAL APPENDAGE WITH A CIRCUMFERENTIAL PERICARDIAL EFFUSION. THE VERSACROSS RF WIRE WAS STILL IN THE LEFT ATRIUM WHEN THE PERFORMATION WAS NOTICED. THEN, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE EFFUSION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. THE PATIENT RECOVERED AND IT WAS DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS REPORTED THAT IT IS POSSIBLE THAT THE PERFORATION HAD HAPPENED ALONG WITH WATCHMAN DOUBLE CURVE SHEATH AND VERSACROSS CONNECT DILATOR. POSSIBLY HAPPENED AFTER REMOVAL OF DILATOR AND POSITIONING OF SHEATH INTO AP

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18659893 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Device-Device Incompatibility; Material Deformation; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED DURING A WATCHMAN PROCEDURE TO TREAT RISK OF BLEEDING, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE RIGHT FEMORAL VEIN ACCESS WAS GAINED WITH THE MECHANICAL GUIDEWIRE. THE VERSACROSS DILATOR AND WATCHMAN SHEATH WERE INSERTED AND WHEN THE PHYSICIAN TRIED TO REMOVE THE GUIDEWIRE, THE WIRE BECAME STUCK IN THE DILATOR AND BY PULLING, IT KINKED. BOTH THE DILATOR AND GUIDEWIRE WERE REMOVED. TO RESOLVE THE ISSUE, A NEW KIT WAS OPENED AND THE RADIO FREQUENCY WIRE WAS USED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED VIA GFE (DATED (B)(6) 2023) THE GUIDEWIRE TRACKED UP INTO THE PATIENT ANATOMY IN THE SUPERIOR VENA CAVA (SVC) BUT NOTHING RELEVANT TO PATIENT ANATOMY THAT COULD HAVE LED THIS ISSUE. NO VISIBLE ISSUES NOTED WITH THE GUIDEWIRE UPON UNPACKAGING. THERE WAS NO EXCESSIVE FORCED USED. WHEN INSERTING THE TRANSSEPTAL SYSTEM INTO THE VENA CAVA. THE GUIDEWIRE WAS INSERTED INTO THE SVC AND THE VERSACROSS CONNECT DILATOR AND WAS WERE INSERTED. THEY ATTEMPTED TO REMOVE THE GUIDEWIRE TO INSERT THE VERSACROSS RF WIRE BUT WERE UNABLE TO REMOVE IT AND WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17947005 ↗
• MalfunctionSep 20, 2023Difficult to Remove; Defective Device; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Difficult to Remove; Defective Device; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT HAS BEEN SELECTED FOR A WATCHMAN PROCEDURE TO TREAT A CASE OF A NON-VALVULAR ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT THEY GUIDEWIRE GOT STUCK IN THE DILATOR AS THEY ATTEMPTED TO WITHDRAW IT. THE PHYSICIAN WAS EVENTUALLY ABLE TO WITHDRAW THE WIRE BY USING EXCESSIVE FORCE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782967 ↗
• MalfunctionSep 5, 2023Defective Device; Device Misassembled During Manufacturing /Shipping; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking; Defective Device; Device Misassembled During Manufacturing /Shipping; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PHYSICIAN GAINED ACCESS FROM INFERIOR VENA CAVA (IVC) TO SUPERIOR VENA CAVA (SVC) BY ADVANCING THE SHEATH AND DILATOR OVER THE MECHANICAL GUIDEWIRE AND IT GOT STUCK. HENCE THE ENTIRE ASSEMBLY WAS PULLED OUT OF THE BODY. THE WIRE WAS THEN PULLED OUT OF DILATOR AND IT WAS NOTED THAT IT WAS "SHREDDED/DEGLOVED". IT WAS ALSO NOTED THAT THERE WAS NO ISSUE FOUND WITH THE DILATOR, HENCE THE SAME DILATOR WAS USED. THE VERSACROSS RADIO FREQUENCY WIRE WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE STAFF BELIEVES THAT THE GUIDEWIRE PACKAGED IS THE WRONG SIZE CAUSING COMPATIBILITY ISSUES. RESISTANCE WAS EXPERIENCED DURING LOADING THE MECHANICAL GUIDEWIRE INTO THE DILATOR. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686046 ↗
• MalfunctionJun 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN CASE TO TREAT AN ATRIAL FIBRILLATION (A FIB). DURING THE PROCEDURE THE MECHANICAL GUIDEWIRE (MGW) GOT STUCK IN THE DILATOR AS THE MGW WAS TRACKED UP INTO THE SUPERIOR VENA CAVA. THE MGW WAS REMOVED FROM THE DILATOR AND REPLACED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221189 ↗
• MalfunctionJun 14, 2023Fracture; Difficult to Remove; Physical Resistance/Sticking; Fracture; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE TO TREAT A LEFT ATRIAL APPENDAGE OCCLUSION. DURING THE PROCEDURE, AFTER ADVANCING THE VERSACROSS DILATOR AND FXD WATCHMAN DOUBLE CURVE SHEATH OVER THE MECHANICAL GUIDEWIRE INTO THE SUPERIOR VENA CAVA, THE PHYSICIAN WAS UNABLE TO REMOVE THE MECHANICAL GUIDEWIRE FROM THE DILATOR, SINCE THE MECHANICAL GUIDEWIRE KINKED, AND IT GOT STUCK IN THE DILATOR, THUS, BOTH THE DILATOR AND THE MECHANICAL GUIDEWIRE WERE REMOVED. UPON REMOVAL FROM THE PATIENT'S BODY, IT WAS APPARENT THAT THE MECHANICAL GUIDEWIRE WAS TRACKED UP INTO THE INFERIOR VENA CANA, THERE WAS AN INFERIOR VENA CANA FILTER PRESENT BUT DID NOT APPEAR TO CAUSE ANY ISSUES. THUS, A NEW VERSACROSS KIT WAS OPENED TO BE USED, WITHOUT ANY ISSUES. IT APPEARS THAT THE MECHANICAL GUIDEWIRE WAS BROKEN OR FRACTURED UPON REMOVAL FROM THE DILATOR, AND TO HAVE UNRAVELED AT THE END. THE DEFECTIVE GUIDEWIRE WAS FULLY RETRIEVED/RECOVERED, AND THE GUIDEWIRE REMAINED IN ONE PIECE. NO OTHER ISSUE WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126484 ↗
• MalfunctionApr 25, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE FOR A WATCHMAN LAA CLOSURE. THE VERSA-CROSS CONNECT DILATOR GOT DAMAGED WHEN TRYING TO GET IT OUT OF THE PACKAGE (IT IS BROKEN). IT WAS NEEDED TO OPEN ANOTHER KIT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WILL NOT RETURN FOR INVESTIGATION. 06APR2023 RECEIVED RESPONSE FOR GFE: THE EVENT HAPPENED RIGHT BEFORE WE GOT STARTED ON A WATCHMAN PROCEDURE ON (B)(6). IT'S HAPPENED ABOUT 2:19 PM. IT HAPPENED DURING PROCEDURE RIGHT BEFORE WE WERE ABOUT TO GO TRANSSEPTAL. THERE WERE NO PATIENT COMPLICATIONS. YES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. WE JUST HAD TO OPEN ANOTHER KIT AND THEY WOULD LIKE TO HAVE THE OTHER KIT REPLACED. NO, THE DEVICE CANNOT BE RETURNED BECAUSE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809888 ↗