VersaCross Connect™ LAAC Access Solution VXAK0107Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00685447019497), received between May 7, 2025 and Sep 28, 2026 — classified as 3 deaths, 39 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Difficult to Advance

  Patient problems: Pericardial Effusion

  MAUDE report 50916423 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pericardial effusion, cardiac tamponade and hypotension.During a left atrial appendage closure (LAAC) procedure, a Versacross RF wire was selected for transseptal access. Prior to the procedure, a small pericardial effusion was identified on imaging. The WATCHMAN FXD Curve Access System (WAS) with VersaCross RF wire was positioned posteriorly for the initial transeptal puncture (TSP). The physician reported difficulty advancing the sheath across the septum. A second transseptal puncture was subsequently performed. The RF wire was advanced into the left atrial appendage (LAA) and then exchanged for a pigtail catheter. A 24 mm WATCHMAN FLX Pro LAA Closure and Delivery System (WDS) was initially selected; however, the device appeared too distally pinched and was removed. The device was exchanged for a 20 mm WATCHMAN FLX Pro WDS. The 20 mm WATCHMAN FLX Pro device was successfully deployed and implanted in the LAA. At the conclusion of the procedure, the pre-existing pericardial effusion was noted to have increased in size and the patient blood pressure decreased. A pericardiocentesis was performed, and approximately 550 cc of bright red bloo

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

  MAUDE report 50854472 ↗
• InjurySep 21, 2026Device Sensing Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50849209 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50848977 ↗
• MalfunctionSep 18, 2026Nonstandard Device

  It was reported that during a WATCHMAN FLX Pro implantation procedure, a VersaCross Connect LAAC Access Solution kit was selected for use in the transseptal puncture. Tip damaged was observed during insertion of the dilator into the sheath, and the original access kit was not used. It was noted that the dilator tip looked jagged. A new VersaCross Connect LAAC Access Solution kit was used to complete the procedure as planned. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817243 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pericardial effusion after the transseptal puncture (TSP).During a concomitant left atrial appendage procedure (LAAC) and radiofrequency (RF) ablation procedure a VersaCross Connect LAAC Access Solution RF Wire was used. Femoral access was gained; a non-Boston Scientific Intracardiac Echocardiography (ICE) catheter was inserted into the right atrium (RA), a non-Boston Scientific coronary sinus (CS) catheter was inserted and positioned at the CS, and a non-Boston Scientific sheath was inserted over a non-Boston Scientific .032-inch J-tip guidewire and positioned at the septum. The J-wire was exchanged for the VerasCross Connect RF Wire and the TSP was performed. The non-Boston Scientific sheath dilator was used with the RF Wire. The physician was not satisfied with the position of the TSP, so the RF Wire was pulled back into the RA, and the TSP procedure was repeated in an inferior/posterior location. Difficulty was encountered advancing the sheath across the septum, and the physician had to push a little harder to get it across. It was stated that the RF Wire may have also advanced across the septum when the sheath did. A routine imaging

  Patient problems: Pericardial Effusion

  MAUDE report 50691337 ↗
• InjurySep 2, 2026Difficult to Advance

  It was reported a pericardial effusion occurred. VersaCross Connect Access Solution was selected for use. Transesophageal Echocardiography (TEE) imaging noted a trace effusion prior to the procedure. The initial transeptal puncture (TSP) was difficult to perform due to a sharp posterior-inferior bend in the patient's anatomy. The physician attempted to cross the septum several times using the VersaCross Connect wire, crossing was made with the same RF wire. A proximal and distal bend were added to the TruSteer sheath and dilator, same dilator was use. After physician deployed the Closure Device, and completed a sweep, TEE imaging showed no change in effusion. Approximately thirty minutes post deployment, the patient's blood pressure dropped. TEE imaging noted the effusion near the apex of the left ventricle. Physician performed a pericardiocentesis to treat the effusion, draining an unknown amount of dull colored fluid. Patient was stabilized and was admitted to intensive care unit. There were no further complications and approximately three days post procedure, the patient was discharged.It was further confirmed that RF was applied each time. Multiple attempts required to track up

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50572336 ↗
• InjurySep 2, 2026Positioning Failure

  It was reported a pericardial effusion occurred. VersaCross Connect Access Solution was selected for use. Transesophageal Echocardiography (TEE) imaging noted a trace effusion prior to the procedure. The initial transeptal puncture (TSP) was difficult to perform due to a sharp posterior-inferior bend in the patient's anatomy. The physician attempted to cross the septum several times using the VersaCross Connect wire, crossing was made with the same RF wire. A proximal and distal bend were added to the TruSteer sheath and dilator, same dilator was use. After physician deployed the Closure Device, and completed a sweep, TEE imaging showed no change in effusion. Approximately thirty minutes post deployment, the patient's blood pressure dropped. TEE imaging noted the effusion near the apex of the left ventricle. Physician performed a pericardiocentesis to treat the effusion, draining an unknown amount of dull colored fluid. Patient was stabilized and was admitted to intensive care unit. There were no further complications and approximately three days post procedure, the patient was discharged.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50568660 ↗
• MalfunctionAug 12, 2026Material Perforation; Sharp Edges

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228391 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that periaortic hematoma occurred. The procedure was cancelled/rescheduled. It was reported that VERSACROSS CONNECT was selected for use during Watchman Left Atrial Appendage Closure (LAAC). It has been mentioned that versacross connect and trusteer were at the Interatrial Septum (IAS)- mid/mid position. When crossing the septum with the versa cross connect, the wire knicked the aorta and caused a periaortic hematoma. Sheath crossed into left atrium and pigtail exchanged overwire. Monitor for 30 minutes and protamine was given to resolve the event. CT surgery consulted, no intervention occurred. Decision was made to abort. The patient is alive and discharged. Patient required care in a step down bed for overnight monitoring. No additional intervention was required, a CT was obtained immediately post procedure and then a repeat CT was performed next morning. Anatomy was a windsock, had limited coaxial depth but depth to access anteriorly.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 50196802 ↗
• DeathAug 5, 2026Adverse Event Without Identified Device or Use Problem

  The patient died.It was reported that during a Watchman Procedure Left Atrial Appendage Closure (LAAC). The doctor was waiting until he got the fluro shot of the appendage to see which rep/device he was going to use. The patient at the beginning of the procedure had a baseline effusion, and very calcified valves. He went transseptal with a Versacross fixed system, and then lost access, resulting in him going back to the right side. He asked for a Trusteer due to the thickness of the septum, and right as he put it up, he noticed a drop in pressure. The patient had suffered a pericardial effusion, and the doctor immediately grabbed a Pericardiocentesis kit, also open-heart surgery and auto-transfusion were performed. However, the patient's ACT was 540, and after 20 minutes and a lot of protamine, it still was at 477. The patient was then wheeled off to the operating room for CT surgery. It was learned that the patient had passed. It is unknown the exact cause of death, but the doctor did not credit it to any device/sheath. Device was disposed.

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

  MAUDE report 50147153 ↗
• InjuryJul 30, 2026Difficult to Advance

  It was reported that pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure Device, Delivery System (WDS), VersaCross Connect RF Wire and VersaCross Connect Dilator were selected for use. Intracardiac echo (ICE) imaging was used initially but was difficult to see due to the patient anatomy. Transesophageal echocardiography (TEE) imaging and intracardiac echocardiography (ICE) were used during the procedure, with TEE serving as the primary imaging modality. Pre-imaging was completed to see the size and morphology of the appendage as well as to scan for an effusion. There was no trace effusion noted. Access was obtained in the right femoral vein. A standard J-wire was inserted in the inferior vena cava (IVC) to the superior vena cava (SVA), followed by the double curve sheath and the VersaCross Connect. The J-wire was removed and replaced with RF wire. The physician used TEE for proper positioning for the transeptal puncture (TSP). Due to the anatomy of the patient, the TSP was limited on where it could cross the septum. There was difficult patient anatomy th

  Patient problems: Pericardial Effusion

  MAUDE report 50090542 ↗
• InjuryJul 30, 2026Difficult to Advance

  It was reported that pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure Device, Delivery System (WDS), VersaCross Connect RF Wire and VersaCross Connect Dilator were selected for use. Intracardiac echo (ICE) imaging was used initially but was difficult to see due to the patient anatomy. Transesophageal echocardiography (TEE) imaging and intracardiac echocardiography (ICE) were used during the procedure, with TEE serving as the primary imaging modality. Pre-imaging was completed to see the size and morphology of the appendage as well as to scan for an effusion. There was no trace effusion noted. Access was obtained in the right femoral vein. A standard J-wire was inserted in the inferior vena cava (IVC) to the superior vena cava (SVA), followed by the double curve sheath and the VersaCross Connect. The J-wire was removed and replaced with RF wire. The physician used TEE for proper positioning for the transeptal puncture (TSP). Due to the anatomy of the patient, the TSP was limited on where it could cross the septum. There was difficult patient anatomy th

  Patient problems: Pericardial Effusion

  MAUDE report 50090525 ↗
• DeathJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient death occurred. It was reported that for a Watchman procedure to treat atrial fibrillation a VersaCross Connect LAAC was selected for use. Access was obtained in the left groin with a 12 French (F) for an Intracardiac Echocardiography (ICE) catheter, and access was obtained in the right groin with an 19 French working sheaths for the Watchman Trusteer sheath. The ICE catheter was introduced in the left 12F catheter. The Versacross RF wire was placed in the 18F sheath and followed up using flouro. The Versacross connect and Trusteer sheath went in over Versacross wire and tracked to the superior vena cava (SVC). Transseptal access was obtained in normal fashion with no issue or delay. The transseptal position was inferior/anterior. Bubbles were noted on transseptal puncture, confirming that RF was successfully delivered. The pigtail of RF wire was noted in the the Left Atrial Appendage (LAA) and wire was placed/parked in the LAA. There were no wire Perforation. The physician then flossed the septum with the Watchman access system. The ICE catheter then navigated through transseptal puncture site into the left atrium. The ICE catheter was placed in the

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 50012854 ↗
• InjuryJul 20, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion, cardiac perforation occurred. During a left atrial appendage (LAA) closure procedure using a WATCHMAN FLX Pro in a patient with atrial fibrillation, VersaCross Connect Pigtail RF Wire was used with a non-Boston Scientific sheath and catheter to perform transseptal puncture. The initial attempt to advance the non-Boston Scientific sheath across the septum was unsuccessful. The VersaCross Pigtail RF Wire was withdrawn into the right atrium, and a second transseptal puncture was performed inferior to the original puncture site. Following successful transseptal puncture using the VersaCross Pigtail RF Wire, the non-Boston Scientific sheath, pigtail catheter were advanced. Contrast injection demonstrated contrast within the pericardial space, resulting pericardial effusion. Transesophageal echocardiography (TEE) confirmed compression of the heart due to fluid accumulation within the pericardial space. A pericardiocentesis was performed, and bright red blood was aspirated and transfused back to the patient. An atrial septal defect (ASD) closure device was implanted. The reported perforation site was the posterior wall; however, a specific perfor

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25874102 ↗
• InjuryJul 16, 2026Device Sensing Problem

  IT WAS REPORTED A PATIENT EXPERIENCED A HEMATOMA, CHEST PAIN AND THE PROCEDURE WAS CANCELLED. USING THE VERSACROSS CONNECT SYSTEM INSIDE OF A TRUSTEER SHEATH A TRANSEPTAL RF PUNCTURE WAS MADE. THE PHYSICIAN CROSSED INTO THE LEFT ATRIUM WITH THE VERSACROSS WIRE AND THE IMAGING PHYSICIAN STATED HE DID NOT SEE THE WIRE IN THE LEFT SUPERIOR PULMONARY VEIN. THE WIRE WAS DETERMINED TO BE AT THE BACK WALL OF THE ATRIUM AND THE IMPLANTING PHYSICIAN STATED THAT THE TACTILE FEEDBACK FROM THE WIRE DIDN'T FEEL RIGHT SO HE CHOSE NOT TO PUSH THE SHEATH ACROSS THE SEPTUM. THE IMAGER THEN NOTICED A LARGE HEMATOMA FORMING WITHIN THE WALL OF THE LEFT ATRIUM, SO THE DECISION WAS MADE TO ABORT THE WATCHMAN AND GET A TRANSTHORACIC ECHO WITH A COMPUTED TOMOGRAPHY (CT) TO FOLLOW LATER. THERE IS NO TREATMENT BEING PERFORMED AT THIS TIME. PHYSICIAN ORDERED MULTI-IMAGING MODALITIES FOR FOLLOW UP TODAY AND TOMORROW. LEFT ATRIUM HEMATOMA WITH SOME COMPRESSION OF THE LEFT ATRIUM, CHEST PAIN. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Chest Pain; Hematoma

  MAUDE report 25850258 ↗
• MalfunctionJul 12, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION FOR A PULSE FIELD ABLATION (PFA) PROCEDURE A TRANSSEPTAL DILATOR FROM THE VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE, IT WAS NOTED THAT THE PACKAGING WAS COMPROMISED, STERILE SEAL HAD A GAP. THE VERSACROSS SYSTEM WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED, EVENT OCCURRED BEFORE PATIENT CAME INTO THE LABORATORY. THE DEVICE IS NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791588 ↗
• MalfunctionJul 2, 2026Failure to Advance

  IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) WIRE COULD NOT CROSS THE SEPTUM. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE A VERSACROSS CONNECT LAAC ACCESS SOLUTION RF WIRE WAS USED. THE VERSACROSS CONNECT DILATOR INSIDE THE WATCHMAN TRUSTEER SHEATH WAS ADVANCED TO THE SUPERIOR VENA CAVA (SVC) OVER THE RF WIRE, THEN THE SHEATH AND DILATOR WERE DROPPED ONTO THE SEPTUM AFTER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ENSURED PROPER PLACEMENT TO CROSS THE SEPTUM THE RF WIRE WAS ADVANCED OUTSIDE THE DILATOR 1-2MM. THE BUTTON ON THE GENERATOR TO DELIVER RF ENERGY WAS ACTIVATED, BUT THE WIRE DID NOT CROSS THE SEPTUM. NO ERROR MESSAGE APPEARED. ALL CONNECTIONS WERE CHECKED AND ANOTHER ATTEMPT TO CROSS THE SEPTUM WAS MADE, BUT THE WIRE STILL DID NOT ADVANCE. IT WAS DECIDED TO REPLACE THE RF WIRE, AND TO USE A VERSACROSS FIXED CURVE SHEATH WITH THE RF WIRE. AFTER POSITIONING THE SHEATH AND VERIFYING A PROPER CROSSING POINT WITH TEE AGAIN, THE GENERATOR BUTTON WAS ACTIVATED, AND THE REPLACEMENT WIRE WAS ABLE TO CROSS THE SEPTUM. THE LAAC PROCEDURE WAS THEN CONTINUED AND COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689919 ↗
• MalfunctionJun 4, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING THE FLX PRO LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE VERSACROSS CONNECT LAAC ACCESS SOLUTION KIT WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT DURING THE PROCEDURE THE BAYLIS DILATOR WAS BEING LOADED OVER THE PROXIMAL END OF THE WIRE. BOTH WIRES DELAMINATED FROM THE PROXIMAL TIP. ANOTHER BAYLIS WIRE WAS USED FOR THE PROCEDURE, WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398441 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC TAMPONADE, PERICARDIAL EFFUSION, HYPOTENSION, AND REDUCED NEUROLOGICAL STATUS. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE A VERSACROSS CONNECT LAAC ACCESS SOLUTION RF WIRE WAS USED. WHEN PERFORMING THE TRANSSEPTAL PUNCTURE (TSP) MULTIPLE DROP DOWNS WERE REQUIRED TO GET IDEAL POSITION ON THE SEPTUM. DURING TWO OF THESE ATTEMPTS THERE WAS EVIDENCE THAT THE RF WIRE SEEMED TO SLIP INTO THE LEFT ATRIUM (LA) THROUGH A SMALL OPENING, BUT NO FURTHER DILATION WAS PERFORMED SINCE THE OPENING WAS NOT IN AN IDEAL SPOT. THE TSP WAS PERFORMED INFERIOR AND POSTERIOR BEFORE MOVING ON TO THE LAAC, WHICH WAS COMPLETED WITHIN TWENTY-FIVE MINUTES POST-TSP. A TRIVIAL PERICARDIAL EFFUSION AROUND THE RIGHT SIDED CHAMBERS WAS NOTED ON ECHOCARDIOGRAPHY AT THE END OF THE PROCEDURE, BUT IT WAS NOT DEEMED A CONCERN. WHEN THE PATIENT WAS IN RECOVERY A DROP IN BLOOD PRESSURE OCCURRED AND THE PATIENT BECAME LESS RESPONSIVE. A PERICARDIAL TAP WAS PERFORMED WHICH REMOVED MORE THAN 150CC OF FLUID AND THE PATIENT'S CONDITION IMPROVED. THE PATIENT WAS HOSPITALIZED BUT IS EXPECTED TO FULLY RECOVER.

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

  MAUDE report 25315437 ↗
• MalfunctionMay 6, 2026Difficult to Advance; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A VERSACROSS CONNECT (VCC) LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE CLOSURE WITH WATCHMAN FLX PRO DEVICE PROCEDURE. DURING PROCEDURE, VERSACROSS WAS PROPERLY FLUSHED AND READY FOR USE WITH WATCHMAN FXD DOUBLE CURVE. THE VERSACROSS RF WIRE WAS SAFELY ADVANCED TO THE SUPERIOR VENA CAVA (SVC). WHILE IT WAS TRYING TO INSERT THE VERSACROSS SYSTEM, THE RF WIRE DID NOT SMOOTHLY PASS THROUGH THE VERSACROSS DILATOR AND GOT STUCK AT THE TIP OF THE DILATOR. IT WAS FURTHER NOTED THAT IT HAD APPEARED TO BE A PLASTIC FILM AT THE PROXIMAL END OF THE RF WIRE WHICH IMPEDED THE WIRE TO PASS SMOOTHLY THROUGH THE DILATOR. ALTERNATE VERSACROSS RF WIRE WAS PROVIDED, AND IT SMOOTHLY PASSED THROUGH THE SAME DILATOR ORIGINAL USED. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. RF WIRE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107150 ↗
• MalfunctionMay 5, 2026Off-Label Use; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT FLX PRO PROCEDURE, A VERSACROSS CONNECT LAAC WAS SELECTED FOR USE. RF WIRE WAS INSERTED THRU THE NON-BOSTON SCIENTIFIC ACCESS NEEDLE AND WAS ATTEMPTED TO ADVANCE TO THE SUPERIOR VENA CAVA (SVC). THE WIRE HAD ISSUES ADVANCING TO THE SVC. AFTER SEVERAL ATTEMPTS PHYSICIAN WAS ABLE TO RF ACROSS THE SEPTUM. THE WATCHMAN DILATOR WAS REMOVED AND THE NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS INSERTED. AFTER THE REMOVAL OF THE RF WIRE THE PHYSICIAN NOTICED THE WIRES COATING WAS COMING OFF. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082296 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS), A 20MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS), AND VERSACROSS CONNECT ACCESS SOLUTION WERE SELECTED FOR USE. THE WDS WAS ADVANCED, DEPLOYED, AND SUCCESSFULLY RELEASED IN THE LEFT ATRIAL APPENDAGE. POST IMPLANT, AS THE DEVICES WERE BEING REMOVED, THE PHYSICIAN NOTED A PERICARDIAL EFFUSION CARDIAC TAMPONADE AND PERFORATION ON THE IMAGING. THE PATIENT WAS MONITORED BUT EVENTUALLY REQUIRED PERICARDIOCENTESIS TO TREAT THE EFFUSION. APPROXIMATELY 400CC OF BLOOD WAS REMOVED AND TRANSFUSED BACK TO THE PATIENT. THE PATIENT REMAINED STABLE AND WAS SENT TO THE POST-ANESTHESIA CARE UNIT (PACU) FOR RECOVERY. THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 25037041 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A PERICARDIAL EFFUSION AND FISTULA OCCURRED AND PROCEDURE WAS ABORTED. IT WAS REPORTED THAT A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. DURING A WATCHMAN A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A TRANSEPTAL PUNCTURE WAS PERFORMED USING THE VERSACROSS CONNECT LAAC ACCESS SOLUTION AND A TRUSTEER SHEATH. THE PHYSICIAN WAS PERFORMED THE TRANSEPTAL PUNCTURE UNDER FLUOROSCOPIC AND TEE GUIDANCE. THE PUNCTURE WAS PERFORMED AT A LOW-MID ASPECT OF THE FOSSA OVALIS - CONFIRMED BY BIPLANE TEE IMAGING. FOLLOWING RF DELIVERY, THE VERSACROSS WIRE WAS ADVANCED INTO THE LEFT ATRIUM AND IT WAS NOTED THAT THE WIRE WAS ENTERING THE ASCENDING AORTA. THE DILATOR AND SHEATH WERE NOT ADVANCED. THE WIRE WAS PULLED BACK INTO THE RIGHT ATRIUM, AND THE FISTULA WAS NOTED ON TEE. THIS FISTULA CLOSED AFTER 20 MINUTES AND REVERSAL OF HEPARIN WITH PROTAMINE. DURING THIS TIME THE PATIENT WAS NOTED TO HAVE A PERICARDIAL EFFUSION THAT WAS PERFORMED AND APPROXIMATELY 75 TO 100CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. THE PATIENT WAS STABLE AND THE EFFUSION STOPPED. THE PATIENT HAD AN ARTERIAL LINE PLACED FOR HEMODYNAMIC MONITORING, AND CHEST DRAIN IN PLACE. THE PATIENT WAS MONITORED I

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

  MAUDE report 24916000 ↗
• MalfunctionApr 10, 2026Nonstandard Device

  IT WAS REPORTED THAT PRIOR A PROCEDURE A VERSACROSS CONNECT WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE VERSACROSS DILATOR WAS DAMAGED, IT WAS PINCHED AND LOOKED ABNORMAL. THE ENTIRE SYSTEM WAS REPLACED. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842670 ↗