VersaCross Connect™ LAAC Access Solution VXAK0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00685447019473), received between Jun 9, 2025 and Sep 11, 2026 — classified as 1 death, 15 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (4 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion, chest pain, hypotension and thrombosis occurred. During a left atrial appendage closure (LAAC) procedure, a VersaCross Connect LAAC Access Solution was selected for use. The patient was known to have a patent foramen ovale (PFO), an extremely aneurysmal septum, and difficult anatomy with a rotated heart. The procedure was performed under uninterrupted anticoagulation; however, the patient's anticoagulation status prior to the procedure was unknown. After groin access was obtained and before transseptal puncture (TSP), a full dose of heparin was administered. The initial activated clotting time (ACT) was 222 seconds. The implanting physician was reportedly surprised by the low ACT value and instructed that additional heparin be administered, although the amount administered was unknown. ACT values remained below 300 seconds until near the end of the procedure. The physician planned to cross the septum above the PFO device rather than through it. While advancing the looped VersaCross wire toward the superior vena cava (SVC), the wire and sheath repeatedly advanced through the PFO, requiring multiple positioning attempts. Fluoroscopy was used

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 50732343 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac tamponade occurred. A left atrial appendage closure (LAAC) procedure was being performed. A VersaCross Connect LAAC Access Solution kit, WATCHMAN FXD Curve Access System and a 20mm WATCHMAN FLX Pro Delivery System were selected for use. The patient was noted to have a small appendage, making the procedure more challenging. After two attempts and recaptures of the 20mm device a larger 24mm WDS was deployed. As the physician checked the views on the transesophageal echocardiography (TEE) the patient blood pressure dropped. A growing effusion was noted. The physician prepped for pericardiocentesis, and anesthesia worked on stabilizing blood pressure. Cardiac surgery was called in as back up. A pericardial drain was placed and about 450 ml of blood was drained at this point. The 24mm WDS and the double curve WAS were removed. The patient was given protamine to reverse anticoagulation. About 1200ml of blood was drained. The blood was re-transfused back into the patient, and an additional two units of blood were given. The patient continued to decline and was brought to the operating room where the LAA was clipped. After clipping the

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

  MAUDE report 50615752 ↗
• InjurySep 1, 2026Positioning Failure

  During a left atrial appendage closure (LAAC) procedure, a WATCHMAN TruSteer Access System, a 27 mm WATCHMAN FLX Pro LAA Closure Device and Delivery System, and a VersaCross Connect LAAC Access Solution were selected for use. A transseptal puncture was attempted using the VersaCross Connect System with the TruSteer sheath; however, multiple attempts to position the system on the fossa ovalis were unsuccessful, and transesophageal echocardiography (TEE) did not adequately demonstrate septal tenting in either the bicaval or short-axis views. During a subsequent repositioning attempt, the patient developed asystole, and transvenous pacing wires were placed via femoral access to manage the arrhythmia. The physician indicated that inadvertent contact with the atrioventricular (AV) node during positioning attempts may have contributed to the event. No malfunction was observed with the VersaCross device during the procedure, and while the patient had a medical history of permanent atrial fibrillation, it could not be determined whether the arrhythmia was related to this pre-existing condition. No information was available regarding medication administration. The patient recovered appropri

  Patient problems: Arrhythmia; Asystole

  MAUDE report 50546471 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that cardiac perforation, pericardial effusion and hypotension occurred. A pulse field ablation procedure was attempted using a FARADRIVE steerable sheath, VersaCross Connect RF Wire, and VersaCross Connect Dilator. The FARADRIVE steerable sheath was advanced into the patient anatomy, and the Intracardiac echocardiography (ICE) was inserted into the right atrium without any complications. The VersaCross Connect Dilator and VersaCross Connect RF Wire were inserted into the Faradrive sheath and into the right atrium. Transeptal access was gained using the VersaCross RF wire and the physician noticed odd looking tissue at the sight of Transeptal puncture and was unable to cross the FARADRIVE sheath and VersaCross dilator into the left atrium. The VersaCross RF wire, VersaCross dilator and FARADRIVE sheath were withdrawn into the right atrium, and a second Transeptal puncture was performed. Shortly after the second transseptal puncture, the patient became hypotensive and a pericardial effusion and cardiac perforation were identified. The physician performed a pericardiocentesis and the patient was extubated and hospitalized beyond the standard of care.

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

  MAUDE report 50545150 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that thrombosis occurred. A left atrial appendage closure (LAAC) procedure was being performed. A VersaCross Connect LAAC Access Solution kit was used with a WATCHMAN TruSteer Access System (WAS). A full dose of heparin was administered in partial doses after femoral access and before transseptal puncture and then seconds after the puncture was completed. First activated clotting time (ACT), taken about 15 minutes after the first partial dose, was 233. Second ACT, taken after the second partial dose, was 311. Radiofrequency (RF) energy was applied once for crossing. Once across the atrial septum with the TruSteer and the VersaCross Connect, a clot was noted on the VersaCross RF wire. The thrombus was flopping but did not break away and become mobile. The wire, sheath and dilator were removed from the patient, and everything was flushed. The procedure was completed as planned. No patient complications were reported. The patient is stable and was discharged the morning after the procedure. A Transesophageal Echocardiogram (TEE) was used to complete the procedure.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50351082 ↗
• InjuryAug 4, 2026Positioning Failure; Device-Device Incompatibility

  It was reported that a patient experienced Pericardial Effusion. During the transseptal access portion of a left atrial procedure, an VersaCross Connect Transseptal Dilator was selected for use. TEE was performed and confirmed the absence of a pericardial effusion prior to the start of the procedure. The patient had a preexisting PFO. The physician was attempting transseptal puncture and elected to gain transseptal access via the PFO due to its location being conducive to the Watchman procedure. The physician dropped down onto the septum and believed to be aligned with the PFO. A moderate amount of tenting was observed in the area of the PFO. The physician attempted to cross the VersaCross wire through the PFO without RF and believed the wire crossed into the pericardial space. Prior to crossing, the wire was confirmed to be protruding from the dilator, with approximately 1 mm exposed. The physician did not appear to use excessive force during the attempted crossing. No difficulty was reported with imaging or visualizing the wire. The physician subsequently withdrew the wire, re-tented on the septum, and delivered RF at one second constant during a second attempt. TSP was completed

  Patient problems: Pericardial Effusion

  MAUDE report 50135603 ↗
• InjuryAug 4, 2026Difficult to Advance

  It was reported that a patient experienced Pericardial Effusion. During the transseptal access portion of a left atrial procedure, an RF Wire VersaCross was selected for use. TEE was performed and confirmed the absence of a pericardial effusion prior to the start of the procedure. The patient had a preexisting PFO. The physician was attempting transseptal puncture and elected to gain transseptal access via the PFO due to its location being conducive to the Watchman procedure. The physician dropped down onto the septum and believed to be aligned with the PFO. A moderate amount of tenting was observed in the area of the PFO. The physician attempted to cross the VersaCross wire through the PFO without RF and believed the wire crossed into the pericardial space. Prior to crossing, the wire was confirmed to be protruding from the dilator, with approximately 1 mm exposed. The physician did not appear to use excessive force during the attempted crossing. No difficulty was reported with imaging or visualizing the wire. The physician subsequently withdrew the wire, re-tented on the septum, and delivered RF at one second constant during a second attempt. TSP was completed prior to noticing

  Patient problems: Pericardial Effusion

  MAUDE report 50134308 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THIS PATIENT HAS A PANT LEG TYPE LEFT ATRIAL APPENDAGE. VERSACROSS CONNECT WAS USED FOR TSP AND CROSSED WITH THE FIRST BUZZ. FIRST A 24MM WATCHMAN DEVICE WAS ATTEMPTED, THEN A 20 MM WATCHMAN DEVICE. THERE WAS NOT ENOUGH SPACE ON EITHER SIDE OF THE BIFURCATING PECTINATE FOR A WATCHMAN DEVICE TO EXPAND AND ANCHOR INTO TISSUE. EVERY DEPLOYMENT EITHER PUSHED PROXIMAL OR TUGGED PROXIMAL INTO AN UNACCEPTABLE POSITION. THERE WERE 7 DEPLOYMENT ATTEMPTS WITH THE 24MM DEVICE AND 5 ATTEMPTS WITH THE 20MM DEVICE. THEN THE PHYSICIAN DECIDED TO ATTEMPT AN AMULET IMPLANT INSTEAD. PRIOR TO SWITCHING TO AMULET, THE IMAGING PHYSICIAN DID AN EFFUSION SWEEP AND CONFIRMED THERE WAS NO EFFUSION AT THE END OF THE WATCHMAN ATTEMPTS. THERE WAS A FAT PAD PRESENT THAT LOOKED THE SAME AS PRIOR TO CASE START. THE PHYSICIANS ALL REVIEWED PRE PROCEDURE IMAGES AND END OF WATCHMAN CASE IMAGES. THEY THEN PROCEEDED TO TRY A 22MM AMULET, WHICH DID NOT WORK SO THEY DOWNSIZED TO A 20MM AMULET DEVICE. THIS DEVICE WAS RELEASED. CASE ENDED AROUND 4:30 PM, THE PATIENT WAS ADMITTED OVERNIGHT. A NOTIFICATION WAS RECEIVED THE FOLLOWING AFTERNOON BY THE SONOGRA

  Patient problems: Pericardial Effusion

  MAUDE report 25882012 ↗
• MalfunctionJun 5, 2026Material Perforation

  IT WAS REPORTED THAT DURING PREPARATIONS FOR A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR THE TRANSSEPTAL PUNCTURE. UPON REMOVAL FROM THE PACKAGING AND PRIOR TO LOADING VERSACROSS DILATOR INTO WATCHMAN SHEATH, THE TIP OF THE DILATOR WAS FOUND TO BE DAMAGED. UPON CLOSER LOOK, A FRACTURE WAS NOTED ON THE TIP. THE DILATOR WAS REPLACED WITH A SIMILAR DEVICE, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409692 ↗
• InjuryMar 30, 2026Device Sensing Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. DURING A PROCEDURE A VERSACROSS CONNECT RADIOFREQUENCY (RF) WIRE WAS USED TO PERFORM THE TRANSSEPTAL PUNCTURE (TSP). A TRACE EFFUSION WAS NOTED AT THE BEGINNING OF THE PROCEDURE AND AT THE END OF IT. FOLLOWING THE PROCEDURE THE PATIENT SHOWED SIGN OF EFFUSION. IT WAS NOTED THAT THE PATIENT HAD CHALLENGING ANATOMY WHICH MAY HAVE CAUSED A STITCHING EFFECT AND SLOW EFFUSION DURING THE TSP. PERICARDIOCENTESIS WAS PERFORMED IN THE OPERATING ROOM (OR), ALONG WITH A BLOOD PULL THAT WAS REINFUSED INTO THE PATIENT. THE CARDIAC DRAIN WAS LEFT IN THE PATIENT, AND THE PATIENT WAS HOSPITALIZED AS PROGRESS WAS MONITORED. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THERE WAS DIFFICULTY VISUALIZING THE RF WIRE ON THE FIRST PUNCTURE ATTEMPT, AS TENTING OF THE TIP OF THE DEVICE WAS NOT VISUALIZED DUE TO DIFFICULT PATIENT ANATOMY. THE IMAGING MODALITIES USED WERE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FOUR-DIMENSIONAL (4D) INTRACARDIAC ECHOCARDIOGRAPHY (ICE), WHICH HAD SIMILAR ISSUES WITH VISUALIZATION. PATIENT ANATOMY ALSO MADE THE TSP DIFFICULT AND MULTIPLE TRACKDOWNS WERE REQUIRED. THE PE

  Patient problems: Pericardial Effusion

  MAUDE report 24731858 ↗
• InjuryMar 19, 2026Difficult to Advance

  IT WAS REPORTED THAT THE RF WIRE WAS DIFFICULT TO ADVANCE PAST THE PATIENT'S PACEMAKER LEADS, AND PATIENT EXPERIENCED BLEEDING AND CARDIAC PERFORATION DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE AN VERSACROSS RF WIRE WAS USED. PRE-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED NO PERICARDIAL EFFUSION. THE PATIENT HAD A DUAL CHAMBER PACEMAKER AND KNOWN PERIPHERAL VASCULAR DISEASE. ULTRASOUND-GUIDED RIGHT FEMORAL VENOUS ACCESS WAS OBTAINED. DIFFICULTY WAS ENCOUNTERED ADVANCING THE VERSACROSS RADIOFREQUENCY (RF) WIRE PAST THE PACEMAKER LEADS. ONCE POSITIONED IN THE SUPERIOR VENA CAVA (SVC), A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) AND VERSACROSS CONNECT (VCC) SYSTEM WERE INTRODUCED FOR TRANSSEPTAL PUNCTURE (TSP). TEE GUIDANCE WAS USED TO TARGET AN INFERIOR/MID SEPTAL POSITION; HOWEVER, PROLONGED DIFFICULTY WAS ENCOUNTERED ACHIEVING AN OPTIMAL TSP POSITION WITHOUT INTERACTION WITH THE PACEMAKER LEADS. AFTER APPARENT SEPTAL CROSSING AND VISUALIZATION OF THE VCC RF WIRE IN THE LAA ON TEE, RESISTANCE WAS MET WHILE ATTEMPTING TO ADVANCE THE WAS ACROSS THE SEPTUM. THE WAS WAS REMOVED, AND DILATION WAS ATTEMPTED OVER-THE-WIRE WITH A 12 FR DILATOR, BUT RESISTANCE PERSIS

  Patient problems: Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels; Speech Disorder

  MAUDE report 24637866 ↗
• MalfunctionJan 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING THE WATCHMAN PROCEDURE TO TREAT LEFT ATRIAL APPENDAGE CLOSURE VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT VERSACROSS CONNECT WAS PLACED IN THE WATCHMAN SHEATH AND VERSACROSS WIRE WAS USED TO GET TO THE SUPERIOR VENA CAVA (SVC). THE CATHETER WAS NOT ABLE TO REACH THE FOSSA. THE PHYSICIAN THEN REMOVED TO THE DILATE AND RESHAPED THE CONNECT DILATOR TO GET TO FOSSA. THE VERSACROSS CONNECT WAS PUT BACK IN THE WATCHMAN FXD DOUBLE CURVE SHEATH AND REATTEMPTED TO ENGAGE THE SEPTUM. THE PHYSICIAN WAS ABLE TO ENGAGE THE SEPTUM SLIGHTLY AND TRIED TO USE RF ENERGY WITH THE VERSACROSS WIRE TO CROSS. A METAL CONTACT ON THE GENERATOR WAS RECEIVED, AND THE PHYSICIAN THEN TRIED TO CROSS AGAIN WITH THE WIRE BUT ENDED UP DECIDING TO SWITCH TO AN NRG WITH AN SL1 SHEATH. THE DOUBLE CURVE WITH THE CONNECT AND WIRE WAS REMOVED FROM THE BODY AND IT WAS DISCOVERED THAT THE TIP OF THE VERSACROSS PIGTAIL HAD THE COATING PEELED OFF. THE INSULATION STRIPPED AT THE PROXIMAL END OF THE WIRE. THE DILATOR WAS BACKLOADED ONTO THE WIRE INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE DILATOR ONLY WITH THE WIRE STILL INSIDE THE BODY RESHAPED AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959072 ↗
• DeathDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEATH OCCURRED. DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THERE WAS A TRIVIAL PERICARDIAL EFFUSION (PE) NOTED WHEN SWEEPING FOR PRE-EXISTING PE PRIOR TO IMPLANTATION. THE PIGTAIL RF WIRE WAS USED AS THE INTRODUCER/GUIDEWIRE WITH ONLY ONE DROPDOWN BEING PERFORMED TO OBTAIN PROPER POSITION INFERIOR AND POSTERIOR ON THE FOSSA FOR TRANSSEPTAL PUNCTURE. A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SELECTED. FOLLOWING THE CLOSURE DEVICE RELEASE, A SWEEP FOR EFFUSION WAS PERFORMED A MILD INCREASE TO THE TRIVIAL BASELINE EFFUSION WAS NOTED. THE PHYSICIAN OBSERVED THE EFFUSION ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR SEVERAL MINUTES AND DETERMINED THAT IT DID NOT APPEAR TO BE INCREASING. HEPARIN WAS REVERSED AND THE PATIENT WAS TRANSPORTED TO THE RECOVERY AREA WITH ADDITIONAL IMAGING TO BE PERFORMED TO EVALUATE ANY INCREASE TO PERICARDIAL EFFUSION (PE). WHEN ADDITIONAL IMAGING WAS PERFORMED, A SUBSTANTIAL INCREASE WAS IDENTIFIED, AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC CATHETERIZATION LAB AND THE PHYSICIAN PERFORMED PERICARDIOCENTESIS TO DRAIN EFFUSION. THE EFFUSION WAS DRAINED,

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 23831966 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE (TSP) AND THE RF WIRE ADVANCED TO LEFT ATRIUM (LA). THE WIRE WAS THEN VISUALIZED IN THE AORTA ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE WIRE WAS WITHDRAWN BACK TO THE RIGHT SIDE. PATIENT REMAINED HEMODYNAMICALLY STABLE AND NO COMPLICATIONS TRANSPIRED. A REDO TSP WAS PERFORMED. THE CASE ULTIMATELY WAS ABORTED BECAUSE THEY COULD NOT CROSS THE ICE CATHETER FROM THE RIGHT SIDE OF THE HEART TO THE LEFT SIDE. PHYSICIAN WANTED TO ABORT TO PRIORITIZE PATIENT SAFETY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 23696460 ↗
• MalfunctionNov 4, 2025Thermal Decomposition of Device; Display or Visual Feedback Problem; Deformation Due to Compressive Stress; Device Sensing Problem; Mechanics Altered; Thermal Decomposition of Device; Display or Visual Feedback Problem; Deformation Due to Compressive Stress; Device Sensing Problem; Mechanics Altered

  IT WAS REPORTED THAT DURING A ATRIAL FIBRILLATION/ LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) CONCOMITANT PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TRANSSEPTAL PUNCTURE (TSP) AND THE VERSACROSS WIRE WAS ADVANCED HOWEVER THE PHYSICIAN WAS UNSURE IF IT WAS IN THE LEFT ATRIUM. NOT BEING ABLE TO CONFIRM LOCATION, THE TRANSSEPTAL WAS REDONE. UPON REMOVAL, THE WIRE WAS OBSERVED AS MANGLED WITH THE PIGTAIL HAVING LOST ITS CIRCULAR SHAPE. THUS, A NEW VERSACROSS WIRE WAS OPENED WITH SUCCESSFUL TRANSSEPTAL PUNCTURE PERFORMED. RF WAS ONLY APPLIED ONCE. THERE WERE NO COMMENTS ABOUT RESISTANCE, ONLY QUESTIONS ABOUT NOT VISUALIZING THE SHEATH IN THE LEFT ATRIUM (LA). TENTING WAS CONFIRMED BY OPERATOR AND IMAGER AS LOW ON THE FOSSA BUT IN AN ACCEPTABLE PLACE TO CROSS. THE WIRE APPEARED TO ADVANCE INTO THE LA INITIALLY WITH MICROBUBBLE OBSERVED ON TEE, BUT IT WAS NEVER CLEARLY SEEN AS IT TYPICALLY APPEARS. IT WAS DIFFICULT TO VISUALIZE. IT WAS NOT POSSIBLE TO LOCATE THE WIRE AFTER THE FIRST TSP ATTEMPT, SO ANOTHER WAS DONE WHICH WAS EASY TO SEE. ANATOMY WAS NOT DIFFICULT, JUST APPEARED TO BE IN THE LOWER AND POSSIBLY THICKER AREA OF THE SEPTUM. TEE, ICE, FLOURO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468585 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. RIGHT FEMORAL ACCESS WAS OBTAINED, THE PATIENT WAS GIVEN 17,000 UNITS OF HEPARIN, VERSACROSS WIRE WAS ADVANCED TO SUPERIOR VENA CAVA (SVC), SHORT SHEATH EXCHANGED FOR VERSACROSS CONNECT DILATOR WITHIN A WAS SHEATH, TRANSSEPTAL ACCESS PERFORMED WITHOUT ISSUES OR CONCERNS. THE PIGTAIL LOOP OF THE WIRE WAS IN THE LAA WHILE THE WAS SHEATH WAS ADVANCED INTO THE LEFT ATRIUM (LA). THE PHYSICIAN MONITORED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). PIGTAIL CATHETER ADVANCED INTO THE LAA. NO CONTRAST INJECTIONS WERE PERFORMED AS THIS PHYSICIAN DOES NOT USE CONTRAST. THE 27MM WDS WAS PREPPED BY THE SCRUB TECH AND PHYSICIAN AT THE STERILE FIELD USING THE MANIFOLD FOR FLUSH. PIGTAIL CATHETER REMOVED, WDS WAS ADVANCED. THE LAA ANATOMY HAD A TALL PECTINATE BIFURCATING THE ANTERIOR LOBE FROM THE POSTERIOR SPACE AND THERE WAS A SMALL PROXIMAL TRABECULATION CLOSE TO THE OSTIUM ON THE POSTERIOR SIDE. THE PHYSICIAN USED TEE AND FLUOROSCOPY IMAGING TO BRING THE WDS UP TO THE LAA, UNSHEATHING TO A FLEX BALL, ADVANCED 1-2MM INTO THE A

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 23451487 ↗
• MalfunctionSep 22, 2025Nonstandard Device; Defective Device; Device-Device Incompatibility; Nonstandard Device; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. UPON OPENING THE FIRST VERSACROSS CONNECT, THE SCRUB TECH AND PHYSICIAN WAS UNABLE TO LOAD THE WIRE INTO THE VERSACROSS DILATOR. IT APPEARED THAT THE TIP OF THE DILATOR LOOKED LIKE IT WAS FLARED, NO MENTION OF SLITS OR TEARS. THUS, A SECOND VERSACROSS WAS OPENED WHICH HAPPENED TO BE THE SAME LOT NUMBER AND THE SAME ISSUE OCCURRED. THUS, A THIRD KIT WITH DIFFERENT LOT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DILATOR WAS RESHAPED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110680 ↗
• MalfunctionSep 19, 2025Nonstandard Device; Defective Device; Device-Device Incompatibility; Nonstandard Device; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. UPON OPENING THE FIRST VERSACROSS CONNECT, THE SCRUB TECH AND PHYSICIAN WAS UNABLE TO LOAD THE WIRE INTO THE VERSACROSS DILATOR. IT APPEARED THAT THE TIP OF THE DILATOR LOOKED LIKE IT WAS FLARED, NO MENTION OF SLITS OR TEARS. THUS, A SECOND VERSACROSS WAS OPENED WHICH HAPPENED TO BE THE SAME LOT NUMBER AND THE SAME ISSUE OCCURRED. THUS, A THIRD KIT WITH DIFFERENT LOT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DILATOR WAS RESHAPED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097571 ↗
• InjurySep 17, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A CARDIAC PERFORATION, PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN FLX PRO PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. THERE WAS NO BASELINE EFFUSION NOTED PRIOR TO PROCEDURE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE (TSP) WHERE THE VERSACROSS RF WIRE WAS ADVANCED AND PULLED BACK THREE TIMES. THE PATIENT WAS STABLE THROUGH THE CONTRAST SHOT IN THE LEFT ATRIAL APPENDAGE (LAA). THE NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS REMOVED, SAFELY UNSHEATHED TO FLX BALL AND AT THAT MOMENT A DROP IN PRESSURE WAS NOTED. THE LOWEST PRESSURE DROP WAS 49MMHG. THE PATIENT WAS TAPPED AND AUTOTRANSFUSION THROUGH A SHORT SHEATH WAS STARTED. AN ADDITIONAL TWO UNITS OF BLOOD WERE TRANSFUSED ONCE AVAILABLE. AFTER THE PATIENT WAS STABLE, CONTRAST SHOT WAS RE-PLAYED. UPON SECOND VIEWING OF CONTRAST SHOT INTO LAA, A PERFORATION APPEARED TO BE IN BACK OF ANTERIOR LOBE OF LAA, WITH CONTRAST LEAKING THROUGH TO PERICARDIAL SPACE. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT OUTCOME WAS NOT DISCLOSED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

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

  MAUDE report 23077243 ↗
• MalfunctionAug 13, 2025Contamination; Contamination

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION SELECTED FOR LAAC PROCEDURE. STAFF WAS OPENED THE PRODUCT AND IT WAS REPORTED THAT THE PRODUCT WAS CONTAMINATED. PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING DIFFERENT DEVICE, SAME MODEL. NO PATIENT WAS PRESENT WHEN THE EVENT HAPPENED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS DISPOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798369 ↗
• InjuryJul 16, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A HEMATOMA, 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. THERE WAS NO EFFUSION NOTED PRIOR TO PROCEDURE. USING WATCHMAN SHEATH AND VERSACROSS SYSTEM, THE PHYSICIAN TENTED THE SEPTUM AND A MID-SUPERIOR AND MID-POSTERIOR PUNCTURE WAS SELECTED BASED ON THE LEFT ATRIAL APPENDAGE (LAA) ANATOMY. THE TENTING WAS VISUALIZED MID AND POSTERIOR ON CORRESPONDING BICAVAL AND SHORT AXIS TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) VIEWS. THE PHYSICIAN EXPOSED THE VERSACROSS RADIO FREQUENCY (RF) WIRE 1-3MM FROM THE TIP OF THE DILATOR IN THE USUAL FASHION. TENTING VISUALIZED AND RF DELIVERY WAS ATTEMPTED. AT THIS POINT, THE TENT WAS POSTERIOR IN THE SHORT AXIS AND SLIDE ANTERIOR AS RF WAS TURNED ON. BUBBLES WERE NOT VISUALIZED IN THE LEFT ATRIUM AND ACCESS TO LEFT ATRIUM WAS NOT GAINED. THE RF WIRE WAS VISUALIZED ON FLOURO RETRACT/CURL BACK ON ITSELF ON THE RIGHT SIDE OF THE HEART. THE WIRE WAS IMMEDIATELY RETRACTED INTO THE DILATOR AND REMOVED OFF THE SEPTUM. THE TEE IMAGER NOTED A ANTERIORLY PERICARDIAL EFFUSION THAT WAS NEW.

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

  MAUDE report 22520765 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR WATCHMAN PROCEDURE. DURING THE PROCEDURE WHEN THE RF WIRE WAS INSERTED INTO THE SHEATH THE RF WIRE DID NOT CAME OUT OF THE SHEATH. THE RF WIRE GOT STUCK IN THE SHEATH. THUS THE RF WIRE WAS REPLACED WITH ANOTHER SAME MODEL DIFFERENT KIT 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 22511580 ↗
• MalfunctionJul 8, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT WHEN DEVICE WAS BEING PREPARED IT WAS NOTED THAT THE INNER DILATOR TIP WAS DAMAGED UPON INSERTING IT INTO THE WM SHEATH. HENCE, THE DEVICE WAS REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438231 ↗
• InjuryJun 12, 2025Display or Visual Feedback Problem; Positioning Problem; Display or Visual Feedback Problem; Positioning Problem

  IT WAS REPORTED A VESSEL PERFORATION OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE, A VERSACROSS CONNECT LAAC KIT WAS SELECTED FOR USE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING OF THE SEPTUM WAS CHALLENGING. TRANSSEPTAL PUNCTURE LOCATION APPEARED TO BE INFERIOR AND MID AP WHEN RF ENERGY WAS DELIVERED THE WIRE WAS NOT SEEN IN THE LEFT ATRIUM AND NO BUBBLES WERE SEEN ON TEE. WHEN OBSERVED ON FLUOROSCOPY AND TEE, THE VERSACROSS WIRE WAS IN THE ASCENDING AORTA. ONLY THE VERSACROSS PIGTAIL WIRE WAS ADVANCED AT THIS TIME. THE RF WIRE WAS RETRACTED BACK INTO THE RIGHT ATRIUM. THE PATIENT WAS OBSERVED FOR ABOUT TEN MINUTES WITH REGULARLY CYCLING BLOOD PRESSURES AND REPEATED TEE IMAGING LOOKING FOR EFFUSION OR BLEEDING ISSUES SURROUNDING THE AORTA. THE PATIENT DID NOT EXPERIENCED CHANGES IN PRESSURE, HEART RATE, OR EFFUSION ON TEE. AFTER TEN MINUTES, THE PROCEDURE CONTINUED SUCCESSFULLY. MORE CURVE WAS ADDED TO THE VERSACROSS DILATOR TO ALLOW FOR BETTER POSITIONING AND VISUALIZATION ON TEE. THE TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY PERFORMED IN AN INFERIOR AND MID AP POSITION, AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENCE. THE PATIENT WAS DISCHARGE

  Patient problems: Perforation of Vessels

  MAUDE report 22195381 ↗
• MalfunctionJun 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. THE PHYSICIAN INSERTED THE RF WIRE IN AND UP TO THE SUPERIOR VENA CAVA (SVC). HE THEN WENT TO BACK LOAD THE WATCHMAN SHEATH AND VERSACROSS CONNECT DILATOR OVER THE WIRE AND IT WOULD NOT ADVANCE OVER THE BACK END OF THE WIRE. PHYSICIAN STATED THAT THE WIRE WAS RAISED AT THE PROXIMAL END AND WOULDN'T ALLOW FOR ANY EXCHANGES OVER IT. THUS, A NEW VERSACROSS CONNECT WAS OPENED AND THE TRANSSEPTAL PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167778 ↗