VersaCross Connect LAAC Access SolutionRecalls & reported problems across all models

We found 10 models of VersaCross Connect LAAC Access Solution by Baylis Médicale Cie Inc in the FDA's device registry (GUDID). Together they are named in 301 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2022 and Jul 2, 2026 — classified as 9 deaths, 164 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (70 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VersaCross Connect LAAC Access Solution problems

VersaCross Connect LAAC Access Solution models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VersaCross Connect LAAC Access Solution VXAK0007

  Dilator, Vessel, For Percutaneous Catheterization
  3 deaths108 reports
• VersaCross Connect LAAC Access Solution VXAK0003

  Dilator, Vessel, For Percutaneous Catheterization
  2 deaths70 reports
• VersaCross Connect LAAC Access Solution VXAK0007

  Dilator, Vessel, For Percutaneous Catheterization
  2 deaths54 reports
• VersaCross Connect LAAC Access Solution VXAK0001

  Dilator, Vessel, For Percutaneous Catheterization
  2 deaths18 reports
• VersaCross Connect LAAC Access Solution VXAK0005

  Dilator, Vessel, For Percutaneous Catheterization
  18 reports
• VersaCross Connect LAAC Access Solution VXAK0003

  Catheter, Septostomy
  17 reports
• VersaCross Connect LAAC Access Solution VXAK0005

  Dilator, Vessel, For Percutaneous Catheterization
  9 reports
• VersaCross Connect LAAC Access Solution VXAK0001

  Catheter, Septostomy
  5 reports
• VersaCross Connect LAAC Access Solution VXAK0009

  Dilator, Vessel, For Percutaneous Catheterization
  1 report
• VersaCross Connect LAAC Access Solution VXAK0009

  Dilator, Vessel, For Percutaneous Catheterization
  1 report

Recent VersaCross Connect LAAC Access Solution adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Positioning Failure; Device Sensing Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS PERFORMED. PRE-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED A LIPOMATOUS AND ANEURYSMAL INTERATRIAL SEPTUM. THE PHYSICIAN INITIATED THE TRANSSEPTAL PUNCTURE (TSP) USING A VERSACROSS CONNECT WITH THE TRUSTEER SHEATH TO ACCESS THE SEPTUM. HOWEVER, THE IMAGER WAS UNABLE TO VISUALIZE SEPTAL TENTING IN THE STANDARD TEE VIEWS, AND THE AVAILABLE IMAGES MADE IT DIFFICULT TO IDENTIFY THE EXACT LOCATION OF TENTING. AFTER THREE UNSUCCESSFUL ATTEMPTS TO ADVANCE, THE PHYSICIAN DECIDED TO SWITCH TO A STANDARD VERSACROSS ACCESS SYSTEM. DURING PREPARATION OF THE NEW SYSTEM, IMPROVED IMAGING VIEWS WERE OBTAINED. A PIGTAIL WIRE WAS ADVANCED AFTER ENTERING THE RIGHT ATRIAL APPENDAGE, AND SUCCESSFUL TSP ACCESS WAS ACHIEVED. THE PIGTAIL WIRE WAS THEN POSITIONED IN THE LEFT ATRIAL APPENDAGE (LAA). THE VERSACROSS SHEATH WAS EXCHANGED FOR THE TRUSTEER SHEATH, AND THE DILATOR WAS REMOVED. THE PIGTAIL WIRE WAS SUBSEQUENTLY EXCHANGED FOR A PIGTAIL CATHETER, AND AN APPENDOGRAM WAS PERFORMED. AT THAT TIME, THE IMAGER NO

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25692957 ↗
• DeathJun 23, 2026Off-Label Use; Device Sensing Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. DURING A STROKE PREVENTION WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION RF WIRE AND DILATOR WERE SELECTED FOR TRANSSEPTAL ACCESS. DURING POSITIONING PRIOR TO TRANSSEPTAL PUNCTURE (TSP), THE PHYSICIAN POSITIONED TOO LOW ON THE SEPTUM AND WAS ADVISED BY THE CLINICAL SPECIALIST TO RETURN TO THE SUPERIOR VENA CAVA AND REATTEMPT POSITIONING USING THE WIRE; HOWEVER, THIS RECOMMENDATION WAS NOT FOLLOWED. THE ECHO CARDIOLOGIST ALSO CAUTIONED THAT THE NEEDLE ORIENTATION APPEARED DIRECTED TOWARD THE AORTA. TSP WAS SUBSEQUENTLY PERFORMED. AFTER PUNCTURE, AN ATTEMPT WAS MADE TO ADVANCE THE VERSACROSS WIRE INTO THE LEFT UPPER PULMONARY VEIN (LUPV), BUT VISUALIZATION WAS LOST ON ECHOCARDIOGRAPHY. ALTHOUGH THE WIRE APPEARED TO BE IN POSITION, THE PHYSICIAN REMOVED THE VERSACROSS WIRE AND REPLACED IT WITH A STANDARD 0.035-INCH J-TIP WIRE AGAINST THE CLINICAL SPECIALIST'S ADVICE. A PRE-EXISTING PERICARDIAL EFFUSION OF APPROXIMATELY 10 MM WAS PRESENT BEFORE THE PROCEDURE AND FOLLOWING TSP THE EFFUSION BEGAN TO ENLARGE TO MORE THAN TWICE ITS ORIGINAL SIZE. AS THE EFFUSION INCREASED, HEMODYNAMIC COMPROMISE DE

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

  MAUDE report 25597926 ↗
• InjuryApr 17, 2026Difficult to Advance; Physical Resistance/Sticking

  A FISSURE AND FISTULA OCCURRED. IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. DURING TRANSSEPTAL ACCESS, THE SEPTUM WAS CROSSED IN LOW ANTERIOR POSITION. THE VERSACROSS WIRE INITIALLY ENCOUNTERED THE RESISTANCE, DIFFICULT TO ADVANCE FELT LIKE STUCK AND WAS REPOSITION WITHOUT FURTHER ISSUE. THE SHEATH AND DILATOR WERE THEN ADVANCED SUCCESSFULLY COMPLETED. POST PROCEDURE IMAGING TEE IDENTIFIED A SMALL JET FROM AORTIC ROOT INTO THE LEFT ATRIUM, CONSISTENT WITH FISSURE AND FISTULA. THE PATIENT REMAINED STABLE WITH NO HEMODYNAMIC COMPLICATIONS AND FOLLOW UP WAS PLANNED. PATIENT WAS REPORTED TO BE STABLE WITH PLANS FOR A SIX WEEK TO RECHECK. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE. THE PATIENT PLANNED WAS TO BE DISCHARGED ON (B)(6) 2026.

  Patient problems: Fistula; Perforation of Vessels

  MAUDE report 24916882 ↗
• InjuryJan 27, 2026Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT A CARDIAC PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PATIENT HAD PACEMAKER LEADS AND DUE TO THAT THE FELLOW PHYSICIAN WAS HAVING A HARD TIME NAVIGATING TO THE SUPERIOR VENA CAVA (SVC) WITH VERSACROSS RF WIRE. DURING SEVERAL ATTEMPTS TO CANNULATE THE SVC, AN EFFUSION IN RIGHT ATRIAL WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THUS, A PERICARDIOCENTESIS WAS PERFORMED, AND THE DECISION WAS MADE TO TAKE THE PATIENT FOR SURGICAL REPAIR WHEN EFFUSION DID NOT RESOLVE AFTER. THE PLAN WAS TO HAVE THEM CLIP THE APPENDAGE IN SURGERY. THE PATIENT WAS STABLE UP UNTIL THEY WERE TRANSPORTED TO SURGERY AND THEY WERE HOSPITALIZED BEYOND STANDARD OF CARE. THE PATIENT IS EXPECTED TO FULLY RECOVERY. THE PERFORATION WAS LOCATED AT THE RIGHT ATRIAL (RA), PRIOR TO TRANSSEPTAL ATTEMPT. THE LEFT SIDE WAS NEVER ACCESSED. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME, AND THEY WERE UNDER ELIQUIS DURING THE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24193451 ↗
• InjuryDec 11, 2025Positioning Failure; Device Sensing Problem; Positioning Failure; Device Sensing Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) AND HEMATOMA OCCURRED. DURING A WATCHMAN IMPLANT PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED PRIOR TO PROCEDURE. DURING PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THE INTERATRIAL SEPTUM (IAS) WAS NOTED TO BE DIFFUSELY THICK WITH ONLY A SMALL 0.5-1.0CM THIN PORTION LOCATED ANTERIORLY, AND THE TEAM ANTICIPATED THAT TRANSSEPTAL PUNCTURE (TSP) WOULD BE CHALLENGING. THE PHYSICIAN ATTEMPTED TSP USING THE WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WITH THE VERSACROSS CONNECT. MULTIPLE ATTEMPTS WERE MADE OVER 30-40 MINUTES TO OBTAIN A PERPENDICULAR TENT ON THE THIN PORTION OF THE IAS. ONE ANTERIOR/MID TSP ATTEMPT WAS PERFORMED YET BUBBLES AND THE VERSACROSS WIRE REMAINED ON THE RIGHT ATRIAL SIDE, CONFIRMING UNSUCCESSFUL CROSSING. ONCE A PERPENDICULAR TENT POSITION WAS AGAIN VISUALIZED (MID IN THE BICAVAL VIEW AND ANTERIOR IN SHORT AXIS), A SINGLE RADIOFREQUENCY (RF) PULSE WAS DELIVERED. NO WIRE OR BUBBLES WERE VISUALIZED IN THE LEFT ATRIUM (LA), ALTHOUGH THE PHYSICIAN BELIEVED THE WIRE CROSSING ON FLUOROSCOPY. THE PHYSICIAN ADVANCED THE WAS AND VERSACROSS DILATOR. TEE THEN REVEALED THAT THE WAS

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 23778844 ↗
• InjuryDec 11, 2025Device Sensing Problem; Difficult to Advance; Device Sensing Problem; Difficult to Advance

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) AND HEMATOMA OCCURRED. DURING A WATCHMAN IMPLANT PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THERE WAS NO EFFUSION NOTED PRIOR TO PROCEDURE. DURING PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THE INTERATRIAL SEPTUM (IAS) WAS NOTED TO BE DIFFUSELY THICK WITH ONLY A SMALL 0.5-1.0CM THIN PORTION LOCATED ANTERIORLY, AND THE TEAM ANTICIPATED THAT TRANSSEPTAL PUNCTURE (TSP) WOULD BE CHALLENGING. THE PHYSICIAN ATTEMPTED TSP USING THE WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WITH THE VERSACROSS CONNECT. MULTIPLE ATTEMPTS WERE MADE OVER 30-40 MINUTES TO OBTAIN A PERPENDICULAR TENT ON THE THIN PORTION OF THE IAS. ONE ANTERIOR/MID TSP ATTEMPT WAS PERFORMED YET BUBBLES AND THE VERSACROSS WIRE REMAINED ON THE RIGHT ATRIAL SIDE, CONFIRMING UNSUCCESSFUL CROSSING. ONCE A PERPENDICULAR TENT POSITION WAS AGAIN VISUALIZED (MID IN THE BICAVAL VIEW AND ANTERIOR IN SHORT AXIS), A SINGLE RADIOFREQUENCY (RF) PULSE WAS DELIVERED. NO WIRE OR BUBBLES WERE VISUALIZED IN THE LEFT ATRIUM (LA), ALTHOUGH THE PHYSICIAN BELIEVED THE WIRE CROSSING ON FLUOROSCOPY. THE PHYSICIAN ADVANCED THE WAS AND VERSACROSS DILATOR. TEE THEN REVEALED THAT THE WAS

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 23778821 ↗
• InjuryDec 10, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A CARDIAC TAMPONADE, PERICARDIAL EFFUSION (PE) AND PERFORATION OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN FLX PRO PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. PATIENT'S SEPTAL ANATOMY WAS CHALLENGING TO VISUALIZE; AFTER MINUTES OF CONFIRMING SAFE TRANSEPTAL LOCATION AN RADIO FREQUENCY (RF) APPLICATION WAS PERFORMED AND THE WIRE CROSSED THE SEPTUM. HOWEVER, THE WIRE WENT INTO A TRANSVERSE SINUS AREA LEADING TO BLOOD GETTING INTO THE PERICARDIUM CAUSING A HOLE APPROXIMATELY .035' POSTERIOR TO THE AORTA. THE PATIENT WAS OBSERVED TO BE DEVELOPING AN EFFUSION AND EVENTUALLY DEVELOPED TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 450CC OF BLOOD WAS ASPIRATED FROM THE PERICARDIUM. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER OBSERVATION. AFTER THIRTY (30) MINUTES TO AN HOUR HAD GONE BY, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED TO REASSESS THE EFFUSION. UNFORTUNATELY THE EFFUSION CAME BACK AND THE PATIENT WAS TAKEN TO THE OPERATION ROOM WHERE THE CARDIOTHORACIC SURGEON REPAIRED THE HOLE AND LIGATED THE APPENDAGE WITH AN ATRICLIP. THE PATIENT IS EXPECTED TO FU

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Pericardial Effusion

  MAUDE report 23773807 ↗
• InjuryNov 24, 2025Difficult to Advance; Difficult to Advance

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

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

  MAUDE report 23638027 ↗
• 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 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A THROMBUS HAS OCCURRED. IT WAS THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. AFTER CROSSING THE SEPTUM, A THROMBUS FORMATION WAS SUSPECTED LOCATED ON THE VERSACROSS RF WIRE. THE RF WIRE WAS REMOVED, BLOOD WAS ASPIRATED THROUGH THE SHEATH REVEALING A THROMBUS. ACTIVATED CLOTTING TIME (ACT) WAS 314, PATIENT WAS GIVEN 10,000 UNIT OF HEPARIN PLUS ADDITIONAL HEPARIN DURING PROCEDURE. NO FURTHER COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23065952 ↗
• 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 ↗

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