VersaCross Connect LAAC Access Solution VXAK0003 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00685447012573), received between Dec 1, 2022 and Nov 4, 2024 — classified as 2 deaths, 35 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (20 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED DURING A PULSE FIELD ABLATION PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE SUCCESSFULLY. THE WIRE WAS ACROSS AND THE PHYSICIAN HAD SOME DIFFICULTY GETTING THE DILATOR TO CROSS THE SEPTUM DUE TO THICK TISSUE. IT WAS ATTEMPTED MULTIPLE TIMES TO PUSH THE DILATOR THROUGH THE SEPTUM WITH NO SUCCESS. THE VERS ACROSS RF WIRE WAS LEFT ACROSS AND THE VERSACROSS DILATOR WAS PULLED OUT. THEN IT WAS DECIDED TO USE THE FARADRIVE DILATOR TO SEE IF ITS STIFFER TIP WOULD ALLOW FOR CROSSING INTO THE LEFT ATRIUM. WHILE PREPPING THE FARADRIVE DILATOR, A THROMBUS WAS NOTED AT THE TRANSSEPTAL SITE. THE PHYSICIAN WAS UNSURE IF THE THROMBUS WAS ATTACHED TO THE WIRE OR THE SEPTUM, HENCE THE WIRE WAS REMOVED. THROMBUS WAS DETACHED UPON REMOVAL OF THE WIRE AND WAS NOT SEEN REMAINING IN THE RIGHT ATRIUM WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) OR UPON REMOVAL AND FLUSHING OF SHEATH/DILATOR. THERE WAS NO INTERVENTION TAKEN. THE PATIENT WAS MONITORED; AND EXPECTED TO FULLY RECOVER AND IT HAS BEEN DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. A FULL DOSE OF HEPARIN WAS ADMINISTERED BEFORE TSP. NO INTERVENTIO

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20599830 ↗
• InjuryNov 4, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED DURING A PULSE FIELD ABLATION PROCEDURE, A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE SUCCESSFULLY. THE WIRE WAS ACROSS AND THE PHYSICIAN HAD SOME DIFFICULTY GETTING THE DILATOR TO CROSS THE SEPTUM DUE TO THICK TISSUE. IT WAS ATTEMPTED MULTIPLE TIMES TO PUSH THE DILATOR THROUGH THE SEPTUM WITH NO SUCCESS. THEVERSACROSS RF WIRE WAS LEFT ACROSS AND THE VERSACROSS DILATOR WAS PULLED OUT. THEN IT WAS DECIDED TO USE THE FARADRIVE DILATOR TO SEE IF ITS STIFFER TIP WOULD ALLOW FOR CROSSING INTO THE LEFT ATRIUM. WHILE PREPPING THE FARADRIVE DILATOR, A THROMBUS WAS NOTED AT THE TRANSSEPTAL SITE. THE PHYSICIAN WAS UNSURE IF THE THROMBUS WAS ATTACHED TO THE WIRE OR THE SEPTUM, HENCE THE WIRE WAS REMOVED. THROMBUS WAS DETACHED UPON REMOVAL OF THE WIRE AND WAS NOT SEEN REMAINING IN THE RIGHT ATRIUM WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) OR UPON REMOVAL AND FLUSHING OF SHEATH/DILATOR. THERE WAS NO INTERVENTION TAKEN. THE PATIENT WAS MONITORED; AND EXPECTED TO FULLY RECOVER AND IT HAS BEEN DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. A FULL DOSE OF HEPARIN WAS ADMINISTERED BEFORE TSP. NO INTERVENTIONS

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20599773 ↗
• InjuryOct 7, 2024Display or Visual Feedback Problem; Difficult to Advance; Display or Visual Feedback Problem; Difficult to Advance

  A PERICARDIAL EFFUSION AND HYPOTENSION OCCURRED. THE PROCEDURE CANCELLED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS TO RIGHT ATRIUM (RA) WITH THE WAS SHEATH AND A VERSACROSS CONNECT. THE PHYSICIAN MOVED ON TO GETTING TRANSEPTAL ACCESS AFTER GROIN ACCESS. THE WIRE WAS PULLED BACK, AND THE WAS SHEATH/DILATOR WAS THEN PULLED DOWN ON TO THE FOSSA. VISUALIZATION WAS DIFFICULT AT THIS POINT. THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING PHYSICIAN LOST SITE OF THE APPARATUS MULTIPLE TIMES DURING THE TRANSEPTAL ACCESS ATTEMPTS. TO TRY TO SEE BETTER THE PHYSICIAN TRIED A FEW DIFFERENT TIMES TO SLIGHTLY EXTEND THE RF WIRE TIP OUT OF THE DISTAL PART OF THE SHEATH TO VISUALIZE THE APPARATUS BETTER. VISUALIZATION AND SAFE TRANSEPTAL LOCATION WERE OBTAINED TWO TIMES, RADIOFREQUENCY (RF) ENERGY WAS APPLIED THROUGH RF WIRE, BUT ACCESS TO LEFT ATRIUM (LA) DID NOT OCCUR. EVENTUALLY THE PHYSICIAN WAS ABLE TO ACHIEVE A MID AND ANTERIOR STICK OF THE FOSSA AND OBTAINED LA ACCESS ON THE THIRD RF ENERGY APPLICATION USING THE VERACROSS CO

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20389279 ↗
• InjuryOct 7, 2024Positioning Problem; Positioning Problem

  A PERICARDIAL EFFUSION AND HYPOTENSION OCCURRED. THE PROCEDURE CANCELLED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS TO RIGHT ATRIUM (RA) WITH THE WAS SHEATH AND A VERSACROSS CONNECT. THE PHYSICIAN MOVED ON TO GETTING TRANSEPTAL ACCESS AFTER GROIN ACCESS. THE WIRE WAS PULLED BACK, AND THE WAS SHEATH/DILATOR WAS THEN PULLED DOWN ON TO THE FOSSA. VISUALIZATION WAS DIFFICULT AT THIS POINT. THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING PHYSICIAN LOST SITE OF THE APPARATUS MULTIPLE TIMES DURING THE TRANSEPTAL ACCESS ATTEMPTS. TO TRY TO SEE BETTER THE PHYSICIAN TRIED A FEW DIFFERENT TIMES TO SLIGHTLY EXTEND THE RF WIRE TIP OUT OF THE DISTAL PART OF THE SHEATH TO VISUALIZE THE APPARATUS BETTER. VISUALIZATION AND SAFE TRANSEPTAL LOCATION WERE OBTAINED TWO TIMES, RADIOFREQUENCY (RF) ENERGY WAS APPLIED THROUGH RF WIRE, BUT ACCESS TO LEFT ATRIUM (LA) DID NOT OCCUR. EVENTUALLY THE PHYSICIAN WAS ABLE TO ACHIEVE A MID AND ANTERIOR STICK OF THE FOSSA AND OBTAINED LA ACCESS ON THE THIRD RF ENERGY APPLICATION USING THE VERACROSS CO

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20388279 ↗
• InjuryOct 4, 2024Difficult to Advance; Difficult to Advance

  A PERICARDIAL EFFUSION (PE) AND A CARDIAC TAMPONADE OCCURRED. IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. THE PROCEDURE WAS COMPLETED, WHEN THE WATCHMAN SHEATH AND ICE (PHILIPS 4D) CATHETER WERE PULLED BACK INTO THE RIGHT ATRIUM (RA), A LARGE CONCENTRIC EFFUSION MEASURING 11.7MM WAS NOTED AROUND THE RIGHT AND LEFT VENTRICULES ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). A TAMPONADE WAS NOTED, AND THE PATIENT WAS HEMODYNAMICALLY UNSTABLE (SBP 40MMHG). PERICARDIOCENTESIS PERFORMED REMOVING 420CC OF BLOODY FLUID FROM PERICARDIUM WHICH WAS TRANSFUSED BACK TO THE PATIENT. THE DRAIN WAS LEFT IN PERICARDIUM AND REMOVED SEVERAL HOURS LATER AFTER A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED. NO ADDITIONAL FLUID WAS SEEN NOR WAS ANY DRAINAGE SEEN IN THE BAG. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PATIENT HAS BEEN SUCCESSFULLY DISCHARGED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED). NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFARIN BUT TAKING ELIQUIS AT THE TIME. THE PHYSICIAN AND TRANS

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20369202 ↗
• InjurySep 11, 2024Positioning Problem; Positioning Problem

  A PERICARDIAL EFFUSION (PE) OCCURRED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A LEFT ATRIUM APPENDAGE CLOSURE (LAAC). DURING THE TRANSSEPTAL PUNCTURE, IT WAS NOTED THAT THE VERSACROSS RF WIRE DID NOT TRACK NORMALLY INTO THE LEFT ATRIUM (LA). POST DELIVERY OF WATCHMAN DEVICE, DURING ROUTINE PERICARDIAL SWEEP, A PERICARDIAL EFFUSION WAS NOTED AROUND APEX OF HEART AND UNDER RIGHT ATRIUM, AND A PERICARDIOCENTESIS WAS DONE AND PERICARDIAL DRAIN WAS PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS HOSPITALIZED BEYOND STANDARD OF CARE AND WAS DISCHARGED NEXT DAY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO PRIOR EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THERE IS NO REASON TO BELIEVE THAT THE VERSACROSS WIRE MALFUNCTIONED DURING THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE VERSACROSS RF WIRE CONTRIBUTED TO THE EVENT, SINCE DURING TRANSSEPTAL, IT DID NOT TRACK NORMALLY INTO LEFT ATRIUM.

  Patient problems: Pericardial Effusion

  MAUDE report 20194755 ↗
• MalfunctionSep 11, 2024Material Frayed; Difficult to Remove; Physical Resistance/Sticking; Material Frayed; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN VERSACROSS ACCESS SOLUTION WAS SELECTED WATCHMAN PROCEDURE. DURING INSERTION, THE ACCESS WAS GRANTED, AND IT WAS BEING TRIED TO GO UP WITH THE MECHANICAL GUIDEWIRE. HOWEVER, THE GUIDEWIRE GOT STRIPPED AND STUCK UPON TENTATIVE TO REMOVE IT FROM THE DILATOR HUB. ONCE THE GUIDEWIRE WAS REMOVED, IT WAS NOTED TO BE UNRAVELING, IT WAS FULLY RETRIEVED FROM THE PATIENT ANATOMY, AND IT REMAINED IN ONE PIECE. THUS, A NEW VERSACROSS CONNECT KIT WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT RETURNING FOR ANALYSIS AS IT WAS DISCARDED IN FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194665 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HYPOTENSION AND A PLEURAL EFFUSION OCCURRED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN GUIDED THE VERSACROSS RF WIRE TO THE SUPERIOR VENA CAVA (SVC) AS NORMAL, FOLLOWED UP WITH THE VERSACROSS DILATOR AND THE WATCHMAN FXD DOUBLE CURVE SHEATH. TRANSSEPTAL PUNCTURE WAS PERFORMED STANDARD WITH NO ISSUES. AS THE WATCHMAN DEVICE WAS BEING PREPPED ON THE TABLE, THE PATIENT'S BLOOD PRESSURE BEGAN DROPPING TO 35/25, THEREFORE, THE ANESTHESIOLOGIST GAVE MEDICATION TO BRING THE BLOOD PRESSURE UP AND A BOLUS OF FLUIDS. A SWEEP FOR A PERICARDIAL EFFUSION WAS PERFORMED MULTIPLE TIMES OVER THE COURSE OF 5-10 MINS, AND NONE WAS FOUND. A GROIN ART LINE WAS INSERTED AND CHECKED FOR BP AS WELL AND IT WAS CONSISTENT, BY THIS TIME THE BP HAD COME UP TO 120/80 AND THE PROCEDURE WAS FINISHED AS NORMAL WITH ONE DEPLOYMENT OF THE FLX PRO 27MM DEVICE. PASS CRITERIA WERE EVALUATED AND MET, AND THE DEVICE WAS RELEASED. WATCHMAN DELIVERY AND ACCESS SYSTEM WERE THEN REMOVED, AND BP WAS NOT STABLE AGAIN. THE PHYSICIAN THEN PERFORMED A VENOGRAM OF THE IVC AND DIDN'T SEE AN

  Patient problems: Hemothorax; Low Blood Pressure/ Hypotension; Pleural Effusion

  MAUDE report 20135828 ↗
• InjuryAug 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THE PHYSICIAN WENT TRANSSEPTAL INFERIOR/MID-ON SEPTUM, HOWEVER CROSSED THE SEPTUM THROUGH PATENT FORAMEN OVALE (PFO) WITHOUT USING THE RADIO FREQUENCY DELIVERY, THUS, THE DEVICE WAS PULLED BACK. THE RE-POSITIONING OF TRANSSEPTAL DEVICE WAS DONE AND TRANSSEPTAL WAS COMPLETED. THE PATIENT'S BLOOD PRESSURE DROPPED AT THIS POINT, AND THE PHYSICIAN SHOT CONTRAST AND EFFUSION ON RIGHT SIDE OF THE HEART WAS NOTED ON FLUOROSCOPY. THE PROCEDURE WAS CANCELLED AND A TAP WAS PERFORMED, AND 50CC OF BRIGHT FLUID WAS REMOVED. THE PATIENT WAS EXPECTED TO BE FULLY RECOVERED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THERE WAS NO PERICARDIAL EFFUSION OBSERVED PRIOR TO THE PROCEDURE. THE VERSACROSS RF WIRE COULD NOT BE VISUALIZED FOR FEW MINUTES. THE PHYSICIAN WAS USING A NEW ICE CATHETER AND MACHINE, AND SINCE HE WAS NEW TO THE MODALITY, THE SEPTUM WOULD COME IN AND OUT OF VISUALIZATION. IN THE PHYSICIAN'S OPINION, IT IS NOT BELIEVED THE TRANSSEPTAL DEVICE CONTRIBUTE TO THE PATIENT COMPLICATION. NO OTHER ISS

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19959869 ↗
• MalfunctionJul 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR AN ELECTROPHYSIOLOGY STUDY. DURING PREPARATION, IT WAS MENTIONED THAT THE PRODUCT WAS CONTAMINATED AND COULD NOT BE USED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19703125 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED POST SEDATION. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION KIT WAS SELECTED FOR USE. THERE WAS A BASELINE EFFUSION OF ROUGHLY 4 MM NOTED. THE PATIENT WAS ON XARELTO. THE PHYSICIAN USED A STIFF GUIDEWIRE (AMPLATZ SUPER) AND NOTED SOME DIFFICULTY CANNULATING THE INFERIOR VENA CAVA (IVC)/SUPERIOR VENA CAVA (SVC), WHERE THE WIRE WOULD DEFLECT INTO SUB-BRANCHES OR GO OFF PATH. THE PHYSICIAN SUSPECTED THAT THEY MAY HAVE PERFORATED THE RIGHT ATRIAL APPENDAGE. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY WITH VERSACROSS RF WIRE USING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) T A MID-MID TO MID-INFERIOR. THEN, THE TRUSTEER SHEATH WAS CROSSED THE SEPTUM WITHOUT DIFFICULTY. AS THE PHYSICIAN WAS GOING TO INSERT THE CONTRAST SHEATH INJECTION, THE STAFF NOTED THE PATIENT BLOOD PRESSURE DROP TO 53 SYSTOLIC. A REPEAT PRESSURE CYCLED WHILE THE APPENDAGOGRAM WAS COMPLETED. IT WAS NOTED ON ICE AND THE CONTRAST INJECTION HOW HYPERDYNAMIC THE LEFT ATRIAL APPENDAGE (LAA) WAS. ACT AT THIS TIME WAS 331. REPEAT PRESSURE WAS 83 SYSTOLIC. THE

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Loss of consciousness; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19371118 ↗
• InjuryMar 13, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED A HEMATOMA/SWELLING/EDEMA OCCURRED. DURING THE WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS PERFORMING THE TRANSSEPTAL PUNCTURE (TSP) POSITIONING AT MID-INFERIOR AND MID ON THE FOSSA. WHEN RADIO FREQUENCY (RF) WAS DELIVERED, THE PHYSICIAN THOUGHT THAT THE RF WIRE WAS STILL IN THE DILATOR. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS OBSTRUCTING THE VIEW OF THE DILATOR TIP SO ITS PROBE WAS MOVED A BIT AND THE RF WAS DELIVERED AGAIN. THE PHYSICIAN DID NOT REALIZE THAT THE CONNECT DEVICE COULD HAVE MOVED FROM THE TIME OF THE INITIAL RF TO THE TIME THE ACTUALLY WENT ACROSS. AFTER THE WATCHMAN DEVICE WAS RELEASED, THE TEE PHYSICIAN NOTICED A HEMATOMA/SWELLING AROUND THE NON-CORONARY CUSP OF THE AORTIC ROOT WHICH WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE SHUNTING OF THE TRANSSEPTAL PUNCTURE WAS OBSERVED AND IT WAS NOTED VERY ANTERIOR, ALMOST RIGHT NEXT TO THE AORTA. THE CARDIAC SURGEON WAS CALLED AND AORTOGRAM COMPUTED TOMOGRAPHY (CTA) WAS REQUESTED. THE PATIENT WAS KEPT HOSPITALIZED FOR MONITORING. THE CTA RESULTS WERE NORMAL, THE PATIENT REMAINED STABLE (CURRENT STATUS UNKNOWN) AND WILL

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 18899865 ↗
• InjuryMar 13, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED A HEMATOMA/SWELLING/EDEMA OCCURRED. DURING THE WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PHYSICIAN WAS PERFORMING THE TRANSSEPTAL PUNCTURE (TSP) POSITIONING AT MID-INFERIOR AND MID ON THE FOSSA. WHEN RADIO FREQUENCY (RF) WAS DELIVERED, THE PHYSICIAN THOUGHT THAT THE RF WIRE WAS STILL IN THE DILATOR. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS OBSTRUCTING THE VIEW OF THE DILATOR TIP SO ITS PROBE WAS MOVED A BIT AND THE RF WAS DELIVERED AGAIN. THE PHYSICIAN DID NOT REALIZE THAT THE CONNECT DEVICE COULD HAVE MOVED FROM THE TIME OF THE INITIAL RF TO THE TIME THE ACTUALLY WENT ACROSS. AFTER THE WATCHMAN DEVICE WAS RELEASED, THE TEE PHYSICIAN NOTICED A HEMATOMA/SWELLING AROUND THE NON-CORONARY CUSP OF THE AORTIC ROOT WHICH WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE SHUNTING OF THE TRANSSEPTAL PUNCTURE WAS OBSERVED AND IT WAS NOTED VERY ANTERIOR, ALMOST RIGHT NEXT TO THE AORTA. THE CARDIAC SURGEON WAS CALLED AND AORTOGRAM COMPUTED TOMOGRAPHY (CTA) WAS REQUESTED. THE PATIENT WAS KEPT HOSPITALIZED FOR MONITORING. THE CTA RESULTS WERE NORMAL, THE PATIENT REMAINED STABLE (CURRENT STATUS UNKNOWN) AND WILL

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 18899366 ↗
• InjuryMar 6, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A TRIVIAL PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE TO TREAT LEFT ATRIAL APPENDAGE CLOSURE (LAAC), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PATIENT HAD AN ANEURYSMAL SEPTUM, THE PHYSICIAN CROSSED SEPTUM IN AN INFERIOR, MID MANNER. THE VERSACROSS DILATOR AND THE WATCHMAN SHEATH STUCK TENTING AT SEPTUM AND THEN JUMPED ACROSS THE LEFT ATRIUM. THE PATIENT BLOOD PRESSURE DECREASES AND ANESTHESIA STAFF INCREASED THE BLOOD PRESSURE OF THE PATIENT THROUGHOUT THE PROCEDURE. THE LEFT ATRIUM LOOKED COMPRESSED AND A TRIVIAL BASELINE PERICARDIAL EFFUSION WAS NOTED. THE TRIVIAL PERICARDIAL EFFUSION AT BASELINE REMAINED THE SAME AND NO OTHER EFFUSION WAS NOTED. THE PATIENT WAS STABLE, BUT THE PHYSICIAN DID CONTINUE THE PROCEDURE DUE TO THE ATRIUM CHANGING SHAPE AND PATIENT'S LOW BLOOD PRESSURE. PATIENT WENT TO UNIT INTUBATED. THE PROCEDURE WAS ABORTED. COMPUTED TOMOGRAPHY (CT) WILL BE PERFORMED AND THE PATIENT REMAINS UNDER PHYSICIAN MONITORING. IT WAS FURTHER REPORTED CT CONFIRMED A SMALL PERICARDIAL EFFUSION OR HEMATOMA SOURCED FROM TRANSSEPTAL PUNCTURE TO THE LEFT ATRIUM WALL (RESOLVED, PATIENT W

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

  MAUDE report 18848799 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRIVIAL PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE TO TREAT LEFT ATRIAL APPENDAGE CLOSURE (LAAC), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PATIENT HAD AN ANEURYSMAL SEPTUM, THE PHYSICIAN CROSSED SEPTUM IN AN INFERIOR, MID MANNER. THE VERSACROSS DILATOR AND THE WATCHMAN SHEATH STUCK TENTING AT SEPTUM AND THEN JUMPED ACROSS THE LEFT ATRIUM. THE PATIENT BLOOD PRESSURE DECREASES AND ANESTHESIA STAFF INCREASED THE BLOOD PRESSURE OF THE PATIENT THROUGHOUT THE PROCEDURE. THE LEFT ATRIUM LOOKED COMPRESSED AND A TRIVIAL BASELINE PERICARDIAL EFFUSION WAS NOTED. THE TRIVIAL PERICARDIAL EFFUSION AT BASELINE REMAINED THE SAME AND NO OTHER EFFUSION WAS NOTED. THE PATIENT WAS STABLE, BUT THE PHYSICIAN DID CONTINUE THE PROCEDURE DUE TO THE ATRIUM CHANGING SHAPE AND PATIENT'S LOW BLOOD PRESSURE. PATIENT WENT TO UNIT INTUBATED. THE PROCEDURE WAS ABORTED. COMPUTED TOMOGRAPHY (CT) WILL BE PERFORMED AND THE PATIENT REMAINS UNDER PHYSICIAN MONITORING. IT WAS FURTHER REPORTED CT CONFIRMED A SMALL PERICARDIAL EFFUSION OR HEMATOMA SOURCED FROM TRANSSEPTAL PUNCTURE TO THE LEFT ATRIUM WALL (RESOLVED, PATIENT W

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

  MAUDE report 18848787 ↗
• InjuryJan 31, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. A PERICARDIAL EFFUSION WAS REPORTED POST PROCEDURE. AFTER A SUCCESSFUL WATCHMAN FLX IMPLANT, A SMALL PERICARDIAL EFFUSION (PE) WAS FOUND ON THE ANTERIOR SIDE OF THE HEART BE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THERE WERE FOUR (4) ATTEMPTS REQUIRED TO TRACK UP / DROP DOWN INTO POSITION ON SEPTUM BEFORE TRANSSEPTAL WAS PERFORMED. THE PATIENT WAS TAPPED AND TRANSFERRED TO THE FLOOR IN STABLE CONDITION. THUS, THE PATIENT WAS DISCHARGED NEXT DAY NEXT DAY AND IN GOOD CONDITION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. NO OTHER ADVERSE EVENT OR DEVICE MALFUNCTIONS WERE REPORTED. IT WAS DEEMED THAT THE PE HAPPENED PROBABLY DURING TRANSSEPTAL. IN THE PHYSICIAN'S OPINION, THE VERSACROSS RF WIRE CAUSED THE PERICARDIAL EFFUSION. THE PATIENT WAS UNDER ELIQUIS. THE ACT WAS 300+.

  Patient problems: Pericardial Effusion

  MAUDE report 18615465 ↗
• InjuryJan 30, 2024Display or Visual Feedback Problem; Difficult to Advance; Positioning Problem; Display or Visual Feedback Problem; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION AND BLOOD LOSS OCCURRED. DURING A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, A 2MM BASELINE PERICARDIAL EFFUSION WAS IDENTIFIED. THE PATIENT WAS ADMINISTERED HEPARIN PRIOR TO THE TRANSSEPTAL PUNCTURE (TSP), THE ACTIVATED CLOTTING TIME (ACT) WAS 404. DIFFICULTY WAS EXPERIENCED PERFORMING THE TSP DUE TO PATIENT ANATOMY AND ENLARGED ATRIA. DEVICE WAS PULLED OUT SEVERAL TIMES TO ADJUST THE CURVE SHAPE AND ONCE TENTING WAS CONFIRMED, TSP WAS COMPLETED. THERE WAS DIFFICULTY VISUALIZING THE RADIO FREQUENCY (RF) WIRE IN THE LAA FOLLOWING THE TSP. THE BASELINE EFFUSION INCREASED IN SIZE TO 3MM AROUND RIGHT ATRIUM AND A PERICARDIOCENTESIS WAS PERFORMED. APPROXIMATELY ON LITER OF BLOOD WAS REMOVED AND TWO UNITS OF BLOOD WERE TRANSFUSED. THE WATCHMAN DEVICE WAS IMPLANTED SUCCESSFULLY. ANGIOGRAPHY AND TRANSTHORACIC ECHOCARDIOGRAM REVEALED THE PERICARDIAL EFFUSION WAS STABLE. THE PATIENT REMAINED STABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS ADMITTED OVERNIGHT FOR MONITORING AND IS EXPECTED TO FULLY RECOVER. THE DEVI

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

  MAUDE report 18610395 ↗
• MalfunctionJan 30, 2024Difficult 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 VERSA CROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. THE PHYSICIAN ATTEMPTED TO USE VERSA CROSS MECHANICAL GUIDEWIRE TO GO INTO SUPERIOR VENA CAVA (SVC) TO ENGAGE FOSSA. THE MECHANICAL GUIDEWIRE GOT STUCK IN THE VERSA CROSS DILATOR AND GOT UNRAVELED (BUT IN ONE PIECE). THE MGW GOT STUCK TRYING TO WITHDRAW FROM DILATOR, THUS THE VERSA CROSS DILATOR WAS REMOVED AND THE VERSA CROSS RF WIRE INSERTED FOR SUCCESSFUL CASE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO OTHER ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607903 ↗
• InjuryJan 10, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN CASE. THE VERSACROSS CONNECT RF WIRE WAS USED AND PUT IT THROUGH A NON-BOSTON SCIENTIFIC 18G ACCESS NEEDLE AT FEMORAL ACCESS LIKELY CAUSING THE SHEARING (INTACT AND PEELED). THUS, A SECOND VERSACROSS RF WIRE WAS SELECTED FOR USE AND THE SAME ISSUE HAPPENED. AS AN ALTERNATIVE, PHYSICIAN SWITCH TO A NON-BOSTON SCIENTIFIC .032/SL1/BRK, AND UPON INSERTING THIS SYSTEM PHYSICIAN ACCIDENTALLY BUMPED ATRIOVENTRICULAR (AV) NODE CAUSING INSTANT ASYSTOLE IN THE PATIENT. THEREFORE, A CPR WAS NEEDED AND PATIENTS PULSE RETURNED. THREE MORE TIMES PRE-TRANSSEPTAL PATIENT WENT INTO ASYSTOLE AND PULSE RETURNED EACH TIME. ONCE TRANSSEPTAL, NO MORE ASYSTOLE OCCURRENCES HAPPENED AND THE WATCHMAN WAS IMPLANTED SUCCESSFULLY. NO OTHER ISSUES WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IN THE PHYSICIAN'S OPINION, THE VERSACROSS RF WIRES DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE ISSUE WITH THE WIRE HAPPENED DUE TO THE INSERTION OF THE WIRE THROUGH AN 18G ACCESS NEEDLE. OTHER THE RESUSCITATION, A PACER WIRE WAS INSERTED AND UTILIZED ON THE LAST 3 ASYSTOLIC EVENTS. NO OTHER DAMAGE WAS

  Patient problems: Asystole

  MAUDE report 18490325 ↗
• InjuryJan 10, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN CASE. THE VERSACROSS CONNECT RF WIRE WAS USED AND PUT IT THROUGH A NON-BOSTON SCIENTIFIC 18G ACCESS NEEDLE AT FEMORAL ACCESS LIKELY CAUSING THE SHEARING (INTACT AND PEELED). THUS, A SECOND VERSACROSS RF WIRE WAS SELECTED FOR USE AND THE SAME ISSUE HAPPENED. AS AN ALTERNATIVE, PHYSICIAN SWITCH TO A NON-BOSTON SCIENTIFIC .032/SL1/BRK, AND UPON INSERTING THIS SYSTEM PHYSICIAN ACCIDENTALLY BUMPED ATRIOVENTRICULAR (AV) NODE CAUSING INSTANT ASYSTOLE IN THE PATIENT. THEREFORE, A CPR WAS NEEDED AND PATIENTS PULSE RETURNED. THREE MORE TIMES PRE-TRANSSEPTAL PATIENT WENT INTO ASYSTOLE AND PULSE RETURNED EACH TIME. ONCE TRANSSEPTAL, NO MORE ASYSTOLE OCCURRENCES HAPPENED AND THE WATCHMAN WAS IMPLANTED SUCCESSFULLY. NO OTHER ISSUES WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IN THE PHYSICIAN'S OPINION, THE VERSACROSS RF WIRES DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE ISSUE WITH THE WIRE HAPPENED DUE TO THE INSERTION OF THE WIRE THROUGH AN 18G ACCESS NEEDLE. OTHER THE RESUSCITATION, A PACER WIRE WAS INSERTED AND UTILIZED ON THE LAST 3 ASYSTOLIC EVENTS. NO OTHER DAMAGE WAS

  Patient problems: Asystole

  MAUDE report 18490315 ↗
• MalfunctionJan 3, 2024Difficult to Remove; Defective Device; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Defective Device; Device-Device Incompatibility; Physical Resistance/Sticking

  IT HAS BEEN REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE FOR A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. THE PHYSICIAN NORMALLY USES THE VERSACROSS RF WIRE AS A STARTER WIRE. HOWEVER, THIS PATIENT HAD PACEMAKER LEADS, AND IT WAS DECIDED TO ADVANCE WITH THE MECHANICAL GUIDEWIRE. AFTER THE WIRE WAS ANCHORED INTO THE SUPERIOR VENA CAVA (SVC), THE PHYSICIAN ADVANCED THE CONNECT DILATOR AND WATCHMAN SHEATH UP TO THE SVC. THE MECHANICAL GUIDEWIRE GOT STUCK IN THE DILATOR WHEN HE ATTEMPTED TO RETRACT THE WIRE OUT OF THE PATIENT. ULTIMATELY, BOTH THE CONNECT DILATOR AND MECHANICAL GUIDEWIRE WERE REMOVED TOGETHER OUT OF THE WATCHMAN SHEATH. IN ADDITION, THE DILATOR TIP WAS REPORTED TO BE FOUND DAMAGED/DEFECTIVE AFTER IT WAS REMOVED, IT WAS MANUALLY RESHAPED BUT NOT TO AN EXCESSIVE DEGREE. THE GUIDEWIRE WAS EXPOSED TO THE PATIENT WHEN IT GOT STUCK DURING WITHDRAWAL. NO DAMAGED WAS NOTED ON THE GUIDEWIRE AFTER REMOVAL FROM THE BODY OR PRIOR TO INSERTION. NEXT, THE PHYSICIAN INSERTED THE VERSACROSS RF WIRE INTO THE SVC AND LOADED A NEW VERSACROSS CONNECT DILATOR INTO THE WATCHMAN SHEATH OVER IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441449 ↗
• InjuryDec 19, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THERE WERE DIFFICULTIES EXPERIENCED PERFORMING THE TRANSSEPTAL PUNCTURE AND SEVERAL ATTEMPTS WERE MADE FOR ABOUT THIRTY MINUTES BEFORE THE INTERATRIAL SEPTUM WAS SUCCESSFULLY CROSSED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A FREE FLOATING THROMBUS IN THE RIGHT ATRIUM AND HEPARIN WAS ADMINISTERED. ACT DRAWN LATER RESULT WAS 308. THE LEFT ATRIAL APPENDAGE (LAA) PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT DISCHARGED THE SAME DAY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18360609 ↗
• InjuryDec 19, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THERE WERE DIFFICULTIES EXPERIENCED PERFORMING THE TRANSSEPTAL PUNCTURE AND SEVERAL ATTEMPTS WERE MADE FOR ABOUT THIRTY MINUTES BEFORE THE INTERATRIAL SEPTUM WAS SUCCESSFULLY CROSSED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A FREE FLOATING THROMBUS IN THE RIGHT ATRIUM AND HEPARIN WAS ADMINISTERED. ACT DRAWN LATER RESULT WAS 308. THE LEFT ATRIAL APPENDAGE (LAA) PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT DISCHARGED THE SAME DAY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18360306 ↗
• MalfunctionDec 18, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE TO TREAT GASTROINTESTINAL BLEEDING (GIB), A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TO INSERT THE RADIO FREQUENCY WIRE INTO FEMORAL ACCESS. IT WAS NOTED THAT COATING MATERIAL AROUND THE PIGTAIL SHAPE WAS PEELED BACK. THERE WAS DIFFICULTY NOTED IN TRAVERSE INFERIOR VENA CAVA (IVC) WHICH FORCED THE PHYSICIAN TO PULL WIRE OUT AND INSTANTLY NOTICE THE SHEARING. HENCE TO RESOLVE THE ISSUE, THE RADIO FREQUENCY WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED THAT THE WIRE WAS NOT INSERTED THROUGH AN INTRODUCER NEEDLE/CANNULA AND NO OTHER DAMAGE NOTED ON THE WIRE BEFORE OR AFTER THE INSULATION DAMAGE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352864 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A HEMATOMA OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT KIT WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE BEGAN AND THE PHYSICIAN CONFIRMED THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THERE WAS A GOOD TENTING ON THE FOSSA IN BOTH THE BICAVAL AND SHORT AXIS VIEWS. THE AORTIC ROOT WAS NORMAL IN APPEARANCE AND COULD BE VISUALIZED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND JUST FEW SECONDS AFTER, THE AORTIC ROOT INTRAMURAL HEMATOMA WAS NOTED ON TEE (MEDIA PHOTOS ATTACHED). THE WATCHMAN DEVICE WAS PLACED SUCCESSFULLY. THE PATIENT WAS SENT TO COMPUTED TOMOGRAPHY (CT) TO ASSESS HEMATOMA AND ADMITTED OVERNIGHT FOR MONITORING. THE CT SHOWED IMPROVEMENT AND THE PATIENT WAS DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hematoma

  MAUDE report 18204784 ↗