VersaCross Connect LAAC Access Solution VXAK0005 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00685447012580), received between Jan 24, 2023 and Aug 8, 2024 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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.

• MalfunctionAug 8, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. DURING PREPARATION, WHEN OPENING THE DEVICE TO BE USED, IT WAS NOTICED THAT THERE WAS A SMALL HOLE IN THE STERILE SEAL OF IT, THUS IT WAS NOT USED. THE DAMAGE NOTICED WAS NOT CAUSED WHILE THE PRODUCT WAS BEING OPENED, AND NO DAMAGE WAS NOTED IN THE OUTER BOX. THE STERILE BREACH WAS DETECTED, BUT NO FOREIGN MATERIAL WAS OBSERVED. THUS, A NEW VERSACROSS KIT WAS OPENED TO BE USED, 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 19940774 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION (PE), LEADING TO CARDIAC TAMPONADE AND HYPOTENSION OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT WAS REPORTED THAT A TRANSSEPTAL WAS ATTEMPTED BUT FAILED DUE TO AN INCOMPLETE NON-BOSTON SCIENTIFIC GROUNDING PAD CONNECTION. THE VERSACROSS RF WIRE ADVANCED OUT OF HABIT DURING THE ATTEMPT TO DELIVER RADIO FREQUENCY ENERGY, BUT THE VERSACROSS RF WIRE DID NOT CROSS THE SEPTUM. THE NON-BOSTON SCIENTIFIC GROUNDING PAD WAS RECONNECTED AND THE PLACEMENT ON PATIENT WAS DOUBLE CHECKED, ERROR WAS RESOLVED. HOWEVER, ON THE NEXT ATTEMPT TO CROSS, A GROUND PAD ERROR RE-APPEARED. FINALLY, A NEW NON-BOSTON SCIENTIFIC GROUNDING PAD WAS PLACED ON THE OPPOSITE LEG OF THE PATIENT AND RECONNECTED, TRANSSEPTAL WAS THEN COMPLETED WITH NO ISSUES. SHORTLY AFTER, AN EFFUSION WAS SEEN ON THE ECHOCARDIOGRAM ON THE LEFT AND RIGHT VENTRICLES, ALONG WITH HYPOTENSION AND A TAMPONADE IN THE LEFT AND RIGHT VENTRICLES. THE PHYSICIAN OPTED TO MOVE AHEAD WITH THE PROCEDURE AND ATTEMPTED TO PLACE OF A 27MM WATCHMAN DEVICE. THE PE WAS THEN DRAINED BY PERICARDIOCENTESIS, AND THE PHYSICIAN DECIDED TO USE A 2

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

  MAUDE report 19724443 ↗
• InjuryApr 16, 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 FOR WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, WHILE ATTEMPTING TO GO FOR TRANSSEPTAL PUNCTURE USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING, A PERFORATION OCCURRED, AND IT WAS NOTICED A PERICARDIAL EFFUSION THAT WAS NOT PRESENT AT THE BEGINNING OF THE CASE. PROTAMINE WAS GIVEN TO MANAGE THE EFFUSION, AND THEREFORE THE PROCEDURE WAS CANCELLED. THE ISSUE OCCURRED PRIOR TO TRANSSEPTAL. PATIENT WAS ADMITTED TO AN OVERNIGHT STAY, AND IT WAS DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO PE WAS NOTED ON THE ECHO PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT ON WARFARIN OR ANTIPLATELET DRUGS AT THE TIME OF PROCEDURE. IT HAS BEEN FURTHER MENTIONED THAT MULTIPLE ATTEMPTS WERE REQUIRED TO TRACK UP AND DOWN TOWARDS THE SEPTUM. THE ACT WAS THERAPEUTIC DURING THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE VERSACROSS WIRE AND DILATOR DID NOT MALFUNCTION DURING THE PROCEDURE, AND IT IS NOT BELIEVE THE VERSACROSS DILATOR CONTRIBUTED TO THE AE, RATHER THE ICE CATHETE

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19116194 ↗
• InjuryApr 16, 2024Positioning Problem; Positioning Problem

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. A PERFORATION AND A PERICARDIAL EFFUSION (PE) OCCURRED. THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, WHILE ATTEMPTING TO GO FOR TRANSSEPTAL PUNCTURE USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING, A PERFORATION OCCURRED, AND IT WAS NOTICED A PERICARDIAL EFFUSION THAT WAS NOT PRESENT AT THE BEGINNING OF THE CASE. PROTAMINE WAS GIVEN TO MANAGE THE EFFUSION, AND THEREFORE THE PROCEDURE WAS CANCELLED. THE ISSUE OCCURRED PRIOR TO TRANSSEPTAL. PATIENT WAS ADMITTED TO AN OVERNIGHT STAY, AND IT WAS DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO PE WAS NOTED ON THE ECHO PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT ON WARFARIN OR ANTIPLATELET DRUGS AT THE TIME OF PROCEDURE. IT HAS BEEN FURTHER MENTIONED THAT MULTIPLE ATTEMPTS WERE REQUIRED TO TRACK UP AND DOWN TOWARDS THE SEPTUM. THE ACT WAS THERAPEUTIC DURING THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE VERSACROSS WIRE AND DILATOR DID NOT MALFUNCTION DURING THE PROCEDURE, AND IT IS NOT BELIEVE THE VERSACROSS DILATOR CONTRIBUTED TO THE AE, RATHER THE ICE CATHETE

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19115873 ↗
• InjuryDec 20, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION, TAMPONADE, PERFORATION HAS OCCURRED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE VERSACROSS RADIO FREQUENCY WIRE WAS BEING ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) HOWEVER THERE WAS A DIFFICULTY NOTED TO FOLLOW UP TO THE SVC. SOME MANIPULATIONS WITH VERSACROSS AND WATCHMAN SHEATH WAS PERFORMED FOR ABOUT A MINUTE OR TWO TO TRACK WIRE TO THE SVC AND EVENTUALLY FOUND ITS PATH TO THE CORRECT LOCATION. TRANSSEPTAL WAS ACHIEVED WITHOUT ANY ISSUES AND THE WATCHMAN DEVICE WAS IMPLANTED. A SMALL EFFUSION WAS NOTED DURING OUR POST PROCEDURAL CHECK. EFFUSION WAS OBSERVED FOR ABOUT FIFTEEN MINUTES AND WAS COMPARED WITH PRE-CHECK TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING OF THE EFFUSION. IT WAS DIFFICULT TO DETERMINE IF THE EFFUSION WAS PRESENT AT BASELINE BECAUSE OF THE GRAINY-NESS OF OUR PRE-IMAGING. AFTER WAITING FIFTEEN MINUTES, THE EFFUSION WAS UNCHANGED AND VITAL SIGNS WERE STABLE. PATIENT WAS SENT TO RECOVERY AND UPON WAKING BEGAN TO COMPLAIN OF CHEST PAINS AND PRESSURES WERE NOTED TO BE SLIGHTLY HYPOTENSIVE. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS ORDERED AND EFFUSION WAS NOTABLY LARGER THAN IN THE CA

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

  MAUDE report 18365125 ↗
• MalfunctionOct 2, 2023Difficult to Remove; Defective Device; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Defective Device; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A LEFT ATRIUM APPENDAGE CLOSURE. THE MECHANICAL GUIDEWIRE (MGW) WAS INSERTED INTO THE SHEATH AND THEN BECAME STUCK IN THE DILATOR, ONCE THE GUIDEWIRE WAS TRACKED UP INTO THE PATIENT ANATOMY (IVC - INFERIOR VENA CAVA - WAS RELATIVELY STRAIGHTFORWARD). THE DAMAGE WAS OBSERVED WHEN ATTEMPTING TO EXCHANGE THE MECHANICAL GUIDEWIRE OUT FOR THE VERSACROSS RF WIRE. IT WAS NEEDED TO REMOVE THE VERSACROSS DILATOR WITH MECHANICAL GUIDEWIRE FROM THE PATIENTS BODY, AND THE MECHANICAL GUIDEWIRE WAS FORCEFULLY REMOVED OUT OF IT, BUT DAMAGED THE VERSACROSS DILATOR IN THE PROCESS. THUS, A NEW KIT WAS OPENED, TO BE USED ALONG WITH A NON-BOSTON SCIENTIFIC (AMPLATZ) WIRE. IT SEEMS THE INNER MANDRIL OF THE MGW IS DAMAGED AND THE OUTER WINDING IS HOLDING THE WIRE TOGETHER. THE DISTAL END OF MECHANICAL GUIDEWIRE WAS PROTRUDING FROM THE DILATOR WHEN TRACKING UP THE IVC, WHEN IT WAS STUCK. THE GUIDEWIRE WAS FULLY RETRIEVED/RECOVERED FROM PATIENT ANATOMY AND REMAINS IN ONE PIECE. THE COIL OR EITHER END OF THE COIL (IF COIL FRACTURED) ABLE TO BE STRETCHED FREELY. NO OTHER ISSUES WERE NOTED. NO PATIENT COMPLICATIONS WERE REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858276 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY, THE TRANSSEPTAL ACCESS WAS INFERIOR/MID ON THE SEPTUM. THE WATCHMAN SHEATH WAS ADVANCED AND FLX DEVICE WAS ALSO RELEASED SUCCESSFULLY. UPON DEVICES REMOVAL, INTRACARDIAC ULTRASOUND - ICE SHOWED A 1.3MM EFFUSION ON THE POSTERIOR WALL OF THE EPICARDIUM. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS AND WITHDREW ABOUT 550ML FLUID FROM THE PERICARDIUM. ADDITIONAL NON-BOSTON SCIENTIFIC DEVICE WAS USED TO RETURN THE BLOOD BACK TO THE PATIENT AND PATIENT REMAINED STABLE, WAS FULLY RECOVERED AND DISCHARGED FROM HOSPITAL ON (B)(6) 2023. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED. THIS PATIENT WAS ON ELIQUIS. THE INR WAS 1.3, BUT IT WAS NOT ON ANY ANTIPLATELET DRUG. THE PHYSICIAN BELIEVES THE AE WAS DUE TO THE VERY INFERIOR TSP.

  Patient problems: Pericardial Effusion

  MAUDE report 17626738 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY, THE TRANSSEPTAL ACCESS WAS INFERIOR/MID ON THE SEPTUM. THE WATCHMAN SHEATH WAS ADVANCED AND FLX DEVICE WAS ALSO RELEASED SUCCESSFULLY. UPON DEVICES REMOVAL, INTRACARDIAC ULTRASOUND - ICE SHOWED A 1.3MM EFFUSION ON THE POSTERIOR WALL OF THE EPICARDIUM. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS AND WITHDREW ABOUT 550ML FLUID FROM THE PERICARDIUM. ADDITIONAL NON-BOSTON SCIENTIFIC DEVICE WAS USED TO RETURN THE BLOOD BACK TO THE PATIENT AND PATIENT REMAINED STABLE, WAS FULLY RECOVERED AND DISCHARGED FROM HOSPITAL ON (B)(6)2023. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED. THIS PATIENT WAS ON ELIQUIS. THE INR WAS 1.3, BUT IT WAS NOT ON ANY ANTIPLATELET DRUG. THE PHYSICIAN BELIEVES THE AE WAS DUE TO THE VERY INFERIOR TSP.

  Patient problems: Pericardial Effusion

  MAUDE report 17626616 ↗
• MalfunctionAug 17, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE MECHANICAL J-WIRE WAS PLACED INTO SUPERIOR VENA CAVA (SVC). THEN THE WATCHMAN SHEATH AND VERSACROSS DILATOR WAS POSITIONED IN SUPERIOR VENA CAVA (SVC). WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, IT GOT STUCK AND COULD NOT BE ADVANCED OR RETRACTED. THEREFORE, BOTH THE DILATOR AND WIRE WERE REMOVED AND REPLACED WITH THE NEW SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER NOTED THERE WERE NO ISSUES UPON REMOVAL FROM PACKAGING. IT IS SUSPECTED THAT THE WIRE MAY HAVE KINKED WHEN BRINGING THE DILATOR/SHEATH UP THE TORTUOUS ANATOMY. THE GUIDEWIRE DISTAL END PROTRUDING FROM DILATOR. THE WATCHMAN SHEATH REMAINED IN THE BODY AND WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568130 ↗
• MalfunctionAug 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. IT WAS NOTED WHEN THE PHYSICIAN HAD THE SHEATH IN THE SUPERIOR VENA CAVA (SVC), AND WAS ATTEMPTING TO REMOVE THE J-WIRE TO SWAP FOR THE PIGTAIL RF WIRE, THE J-WIRE COULD NOT BE RETRACTED (APPROXIMATELY 5CM OF WIRE SHOWING OUT OF THE END OF THE SHEATH). THE PHYSICIAN WAS UNABLE TO MOVE THE DILATOR ON THE GUIDEWIRE, HENCE THE SHEATH/DILATOR/WIRE WERE REMOVED FROM THE BODY AS ONE SYSTEM WITHOUT HARM. THE GUIDEWIRE WAS FORCEFULLY REMOVED FROM THE DILATOR. THE TROUBLESHOOTING OUTCOME IS UNKNOWN. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER ADVISED THE PHYSICIAN ADDED CURVE ONTO THE SHEATH/DILATOR. THIS WAS PRIOR TO INSERTING THE WIRE INTO THE SHEATH. THERE WERE NO VISUAL ISSUES NOTED ON THE GUIDEWIRE. IT WAS TRACKED UP INTO THE PATIENT ANATOMY BUT THE PATIENT ANATOMY WAS NOT TORTUOUS. THE GUIDEWIRE REMAINED IN ONE PIECE AND ABLE TO STRETCH FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566971 ↗
• MalfunctionAug 17, 2023Difficult to Remove; Defective Device; Component or Accessory Incompatibility; Difficult to Remove; Defective Device; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT LEFT ATRIAL APPENDAGE CLOSURE (LAAC), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. PRIOR TO TRANSSEPTAL PUNCTURE, THE MECHANICAL J-WIRE WAS IN SUPERIOR VENA CAVA (SVC) AND IT FRAYED/ SPLIT WHEN IT WAS PULLED INTO VERSACROSS CONNECT SHEATH. THERE WAS RESISTANCE FELT WHEN WITHDRAWING THE WIRE FROM THE INTRODUCER. BOTH THE VERSACROSS CONNECT AND DOUBLE CURVE SHEATH WERE REMOVED FROM THE BODY. HENCE TO RESOLVE THE ISSUE, A NEW KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565394 ↗
• MalfunctionAug 16, 2023Fracture; Difficult to Remove; Material Deformation; Physical Resistance/Sticking; Fracture; Difficult to Remove; Material Deformation; 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 GUIDEWIRE WAS USED TO ADVANCED SYSTEM IN THE INFERIOR VENA CAVA (IVC) AND AROUND THE PACEMAKER WIRES INTO THE SUPERIOR VENA CAVA (SVC). WHEN THE PHYSICIAN ATTEMPTED TO PULL THE WIRE OUT, THE GUIDEWIRE WAS STUCK IN THE DILATOR. AFTER SEVERAL MINUTES OF TRYING TO ENSURE THE GUIDEWIRE TIP DOESN'T GET STUCK AROUND PACER WIRES, THE DILATOR AND THE GUIDEWIRE WERE REMOVED AND THE WATCHMAN FXD CURVE SHEATH WAS LEFT IN TO MAINTAIN THE ACCESS. ONCE OUTSIDE OF THE PATIENT BODY, THE GUIDEWIRE WAS PUSHED OUT THE DISTAL END OF THE DILATOR AND IT WAS NOTED THAT THE INNER MANDREL OF THE WIRE WAS FRACTURED, AND THE GUIDEWIRE WAS FLIMSY AND FLOPPY. WHEN THE STAFF MEMBER ATTEMPTED TO RETRACT THE MANDREL FROM THE BACK OF THE GUIDEWIRE TO STRAIGHTEN OUT, THE ENTIRE DISTAL TIP OF THE GUIDEWIRE KINKED AND COLLAPSED. HENCE TO RESOLVE THE ISSUE, A NON-BOSTON SCIENTIFIC WIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560292 ↗
• MalfunctionJul 7, 2023Fracture; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking; Fracture; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE. DURING A LEFT ATRIUM APPENDAGE CLOSURE, THE PHYSICIAN WENT UP WITH MECHANICAL GUIDEWIRE AND IT WAS UNABLE TO REMOVE IT AFTER TRANSSEPTAL PUNCTURE, THE ASSEMBLY WAS BROUGHT TO THE SUPERIOR VENA CAVA, ONCE TRYING TO REPLACE THE MECHANICAL GUIDEWIRE BY THE VERSACROSS RF WIRE. THUS, THE VERSACROSS DILATOR WAS REMOVED ALONG WITH THE STUCK MECHANICAL GUIDEWIRE FROM BODY COMPLETELY, AND WAS SHEATH WAS LEFT IN PLACE. THEN, THE MECHANICAL GUIDEWIRE WAS REMOVED FROM DILATOR TIP BY PULLING IT FROM THE DISTAL END, AND IT WAS NOTED KINKED AND UNRAVELING. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS PRODUCT IS PART OF THE 97072033-FA EPFLEX GUIDEWIRE OBSTRUCTION ADVISORY COMMENCEMENT ADVISORY FOR THE J-TIPPED MECHANICAL GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280548 ↗
• MalfunctionJul 7, 2023Fracture; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem; Fracture; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PHYSICIAN GAINED ACCESS WITH J-WIRE INTO THE SUPERIOR VENA CAVA (SVC) FOR TRANSSEPTAL PUNCTURE. HOWEVER, WHILE PULLING THE WIRE OUT, IT UNRAVELED AND WAS LODGED AT THE TIP OF DILATOR. PHYSICIAN PULLED THE WIRE AND DILATOR OUT AT THE SAME TIME. PATIENT WAS STABLE. HENCE, THE PHYSICIAN USED THE PIGTAIL WIRE TO COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280050 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED, WHILE USING A VERSACROSS CONNECT ACCESS SOLUTION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 2-3 MINUTES AFTER RELEASE OF THE CLOSURE DEVICE, JUST PRIOR TO REMOVING THE INTRACARDIAC ECHOCARDIOGRAM CATHETER, A 1.2CM PERICARDIAL EFFUSION WAS OBSERVED AROUND THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED AND 300ML OF FLUID WAS DRAINED. THE DRAIN WAS REMOVED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, PERICARDIOCENTESIS AND AFTERWARDS. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED THE FOLLOWING DAY. SINCE THE DRAINED BLOOD FROM THE PERICARDIOCENTESIS WAS DARK, THE PHYSICIAN SUSPECTED THAT THE PE MAY HAVE ORIGINATED IN THE RIGHT ATRIUM DURING THE TRANSSEPTAL CROSSING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN DID NOT LOOK FOR AN EFFUSION WITH INTRACARDIAC ULTRASOUND PRIOR TO THE PROCEDURE, HOWEVER A CARDIAC COMPUTED TOMOGRAPHY WAS DONE THE DAY BEFORE THAT SHOWED NO EVIDENCE OF A PERICARDIAL EFFUSION. THE PHYSICIAN IS NOT SURE WHEN THE PERICA

  Patient problems: Pericardial Effusion

  MAUDE report 17026656 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED, WHILE USING A VERSACROSS CONNECT ACCESS SOLUTION KIT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 2-3 MINUTES AFTER RELEASE OF THE CLOSURE DEVICE, JUST PRIOR TO REMOVING THE INTRACARDIAC ECHOCARDIOGRAM CATHETER, A 1.2CM PE WAS OBSERVED AROUND THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED AND 300ML OF FLUID WAS DRAINED. THE DRAIN WAS REMOVED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, PERICARDIOCENTESIS AND AFTERWARDS. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED THE FOLLOWING DAY. SINCE THE DRAINED BLOOD FROM THE PERICARDIOCENTESIS WAS DARK, THE PHYSICIAN SUSPECTED THAT THE PE MAY HAVE ORIGINATED IN THE RIGHT ATRIUM DURING THE TRANSSEPTAL CROSSING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE WILL NOT RETURN FOR ANALYSIS SINCE IT WAS DISPOSED. THE PHYSICIAN DID NOT LOOK FOR AN EFFUSION WITH INTRACARDIAC ULTRASOUND PRIOR TO THE PROCEDURE, HOWEVER A CARDIAC COMPUTED TOMOGRAPHY WAS DONE THE DAY BEFORE THAT SHOWED NO EVIDENCE OF A PERICARDIAL EF

  Patient problems: Pericardial Effusion

  MAUDE report 17026446 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION WAS NOTED THAT LEAD TO SURGICAL INTERVENTION WHERE VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS USED. THE PHYSICIAN HAD DIFFICULTY VISUALIZING THE VERSACROSS CONNECT LAAC ACCESS SOLUTION DURING THE FIRST AND SECOND ATTEMPT TO CROSS THE SEPTUM. TRANSSEPTAL PUNCTURE WAS CONFIRMED SUCCESSFUL ON THE THIRD ATTEMPT. AFTER IMPLANTING THE WATCHMAN DEVICE IN THE LEFT ATRIAL APPENDAGE, A FINAL SWEEP WAS CONDUCTED, AND A 2 CM SIZED EFFUSION WAS NOTED IN THE RIGHT VENTRICLE. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REMAINED IN THE ICU AND WAS DISCHARGED THE NEXT DAY. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT FOR THE VERSACROSS CONNECT TRANSSEPTAL DILATOR WHICH IS PART OF THE VERSACROSS CONNECT LAAC ACCESS SOLUTION. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR VERSACROSS RF WIRE WHICH IS PART OF THE VERSACROSS CONNECT LAAC ACCESS SOLUTION WITH THE REPORT NUMBER 3019751610-2023-00011.

  Patient problems: Pericardial Effusion

  MAUDE report 16237549 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION WAS NOTED THAT LEAD TO SURGICAL INTERVENTION WHERE VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS USED. THE PHYSICIAN HAD DIFFICULTY VISUALIZING THE VERSACROSS CONNECT LAAC ACCESS SOLUTION DURING THE FIRST AND SECOND ATTEMPT TO CROSS THE SEPTUM. TRANSSEPTAL PUNCTURE WAS CONFIRMED SUCCESSFUL ON THE THIRD ATTEMPT. AFTER IMPLANTING THE WATCHMAN DEVICE IN THE LEFT ATRIAL APPENDAGE, A FINAL SWEEP WAS CONDUCTED, AND A 2 CM SIZED EFFUSION WAS NOTED IN THE RIGHT VENTRICLE. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT REMAINED IN THE ICU AND WAS DISCHARGED THE NEXT DAY. AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT FOR THE VERSACROSS RF WIRE WHICH IS PART OF THE VERSACROSS CONNECT LAAC ACCESS SOLUTION. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR VERSACROSS CONNECT TRANSSEPTAL DILATOR WHICH IS PART OF THE VERSACROSS CONNECT LAAC ACCESS SOLUTION WITH THE REPORT NUMBER 3019751610-2023-00010.

  Patient problems: Pericardial Effusion

  MAUDE report 16237548 ↗