WATCHMAN™ TruSeal™ Access System M635TU70040Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 08714729965725), received between Feb 7, 2019 and Aug 17, 2022 — classified as 1 death, 39 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 29, 2025Class IOpen, Classified

   Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

   Z-2433-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE PROCEDURE THE ACTIVATING CLOTTING TIME (ACT) WAS 94 SECONDS. HEPARIN WAS ADMINISTERED JUST PRIOR TO TRANS-SEPTAL CROSSING AND ACT WAS THEN NOTED TO BE 277 SECONDS. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS INSERTED. AS THE WAS WAS CROSSING THE SEPTUM, A THROMBUS WAS NOTED ON THE TIP OF THE WAS. THE CLOT WAS ASPIRATED AND THE PROCEDURE CONTINUED. A WATCHMAN FLX CLOSURE DEVICE & DELIVERY SYSTEM WAS INSERTED AND DEPLOYED. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15241791 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AIR EMBOLISM AND ST SEGMENT ELEVATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE AND DELIVERY SYSTEM WAS INSERTED. DURING INSERTION OF THE WDS INTO THE WAS, AIR WAS VISUALIZED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IN THE LAA. THEY WAS USED TO ASPIRATE THE AIR OUT. THE PATIENT EXPERIENCED A DECREASE IN BLOOD PRESSURE AND ST SEGMENT ELEVATION. NOREPINEPHRINE WAS ADMINISTERED. THE AIR RESOLVED, THE PATIENT STABILIZED, AND THE TEAM CONTINUED WITH THE PROCEDURE. THE 27MM WDS WAS EXCHANGED FOR A 24MM WDS WHICH WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN SUSPECTS THE SOURCE OF AIR WAS DUE TO INADEQUATE BLEED BACK ON THE WAS PRIOR TO INSERTION OF THE WDS.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 15204065 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC PERFORATION AND PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). IT WAS REPORTED THE PATIENT HAD NO PERICARDIUM DUE TO PREVIOUS CARDIOTHORACIC SURGERIES AND A PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE CLOSURE DEVICE WAS PARTIALLY DEPLOYED OUTSIDE OF THE HEART BEFORE BEING POSITIONED IN THE LAA. A PERI DEVICE JET WAS OBSERVED AND THE CLOSURE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. AFTER REMOVAL OF THE FIRST CLOSURE DEVICE THE WAS SHEATH PERFORATED THE WALL OF THE LAA. A SECOND 27MM CLOSURE DEVICE WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. ONCE THE PATIENT WAS IN RECOVERY, HEPARIN WAS REVERSED. THE PATIENT REPORTED CHEST PAIN, DISCOMFORT, AND SHORTNESS OF BREATH. THE PATIENT WAS DISCHARGED AND WILL BE MONITORED IN AN OUTPATIENT CLINIC.

  Patient problems: Cardiac Perforation; Chest Pain; Dyspnea; Pericardial Effusion

  MAUDE report 14915507 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. FOLLOWING TRANSSEPTAL PUNCTURE, THE PIGTAIL WIRE WAS LEFT ON THE LEFT SIDE OF THE HEART. A WATCHMAN ANTERIOR CURVE TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED IN THE GROIN, AND AN AIR EMBOLISM WAS SEEN IN THE LAA ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY. THE AIR WAS ATTEMPTED TO BE ASPIRATED WITH A 60CC SYRINGE ON THE SIDE ARM OF THE BOSTON SCIENTIFIC (BSC) SHEATH, BUT THE AIR DID NOT READILY RESOLVE. DUE TO UNFAVORABLE ANATOMY, THE CASE WAS NOT COMPLETED. THE AIR EMBOLISM HAD RESOLVED IMMEDIATELY, AND THE PATIENT FULLY RECOVERED FROM THIS EVENT.

  Patient problems: Air Embolism

  MAUDE report 14251440 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERFORATION WITH PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND THEN BEGAN TO INSERT THE WDS. WHILE INSERTING THE WDS THE PHYSICIAN FELT THE WAS MOVE AND PERFORATE THE LAA OF THE PATIENT. THE PERFORATION RESULTED IN A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS TO TAP AND DRAIN THE FLUID FROM THE EFFUSION. THE EFFUSION WAS TREATED AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THE EFFUSION WAS MONITORED FOR TWO HOURS POST PROCEDURE AND THE PATIENT REMAINED IN THE HOSPITAL FOR 24 HOURS TO BE MONITORED. THERE WERE NO OTHER INTERVENTIONS OR TREATMENTS THAT WERE PERFORMED FOR THE PATIENT. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY FROM THESE EVENTS.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 14196518 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 24MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). UPON IMPLANTATION, THE CLOSURE DEVICE DID NOT MEET PASS (POSITION, ANCHOR, SIZE, SEAL) CRITERIA. THE DEVICE HAD A ONE THIRD TO ONE HALF MITRAL SHOULDER IN THE 135 DEGREE VIEW. THE CLOSURE DEVICE WAS RECAPTURED AND THE WAS WAS WITHDRAWN INTO THE RIGHT ATRIUM. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A FLICKERING OBJECT AT THE SUPERIOR PORTION OF THE ATRIAL SEPTUM NEAR THE TRANSSEPTAL PUNCTURE IN THE RIGHT ATRIUM. THE OBJECT WAS THEN NO LONGER VISIBLE ON TEE. THE PROCEDURE WAS DISCONTINUED AND THE PATIENT WAS TRANSFERRED TO RECOVERY. IN RECOVERY THE PATIENT SHOWED NO ADVERSE SYMPTOMS AND WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT. IT WAS FURTHER REPORTED THAT THE PATIENT STABILIZED AND WAS DISCHARGED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13764735 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). DURING THE PROCEDURE WHEN THE WAS WAS IN THE LEFT ATRIUM AND THE PIGTAIL CATHETER WAS BEING ADVANCED, A THROMBUS WAS VISUALIZED ON THE TIP OF THE WAS. THE THROMBUS WAS ASPIRATED INTO THE SHEATH AND THE SHEATH WAS REMOVED FROM THE PATIENT. THE SHEATH WAS FLUSHED AND A SMALL THROMBUS MEASURING LESS THAN A CENTIMETER EMERGED. THE PROCEDURE WAS CONTINUED AND CONCLUDED SUCCESSFULLY. DURING RECOVERY, THE PATIENT WAS EVALUATED FOR ADVERSE EFFECTS AND NONE WERE OBSERVED. THE PATIENT FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13713315 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND AN ANTERIOR CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). PRIOR TO THE INTRODUCTION OF THE CLOSURE DEVICE WHEN THE PIGTAIL CATHETER WAS REMOVED FROM THE WAS A THROMBUS WAS ALSO REMOVED FROM THE PATIENT. AT THAT TIME THE ACTIVATED COAGULATION TIME (ACT) OF THE PATIENT WAS 176 SECONDS AND AN ADDITIONAL DOSE OF HEPARIN WAS ADMINISTERED. A SECOND ACT WAS TAKEN OF 276 SECONDS. THE SHEATH CATHETER WAS ASPIRATED TO CONFIRM NO ADDITIONAL THROMBUS WAS PRESENT. TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED NO INTRACARDIAC THROMBUS WAS PRESENT. THE VITALS OF THE PATIENT REMAINED STABLE THROUGHOUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING RECOVERY, A COMPUTED TOMOGRAPHY SCAN OF THE HEAD WAS ORDERED FOR MONITORING NEUROLOGICAL FUNCTION. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED WITH A PRESCRIPTION FOR XARELTO.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13623228 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 35MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PATIENT WAS NOT ON ORAL ANTICOAGULANTS (OAC) PRIOR TO THE PROCEDURE. THE PATIENT WAS ON PLAVIX 75MG. THE LAA WAS SLIGHTLY SMOKY AT THE START OF THE PROCEDURE AND WORSENED THROUGHOUT THE PROCEDURE. THERE WAS LITTLE TO NO CONTRACTILITY OF THE LAA. AFTER THE WAS AND PIGTAIL CATHETER WERE IN PLACE, AN ANGIOGRAM WAS PERFORMED. THE WDS WAS PREPPED AND THE PIGTAIL CATHETER WAS REMOVED. THE WDS WAS INSERTED ABOUT ONE-FIFTH OF THE WAY INTO THE WAS SHEATH WHEN, VIA TRANSESOPHAGEAL ECHOCARDIOGRAM, BUBBLES FROM THE SALINE FLUSH HIGHLIGHTED A LONG, FILAMENTOUS HYPERMOBILE ECHO DENSITY AT THE OSTIUM OF THE LAA WHICH WAS CONSIDERED TO BE A THROMBUS. THE THROMBUS WAS NOT ATTACHED TO THE WAS. THE WAS REMOVED FROM THE LAA AND THE THROMBUS REMAINED IN PLACE AND BECAME MORE APPARENT. THE DECISION WAS MADE TO ABORT THE PROCEDURE. THE PATIENT WAS TO START OAC.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13308013 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A DOUBLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. EFFUSION SWEEPS WERE DONE AFTER THE DEVICE WAS DEPLOYED AND REMOVED AND NO EFFUSION WAS NOTED. AFTER EXCHANGING THE DOUBLE CURVE WAS FOR AN ANTERIOR CURVE WAS, THE ANTERIOR CURVE WAS APPEARED TO "JUMP" ACROSS THE SEPTUM. AN EFFUSION SWEEP WAS DONE AND AN EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHO (TEE). THERE WERE NO CHANGES IN PATIENT STATUS AND NO INTERVENTION WAS PERFORMED. THE DEVICE WAS NOT IMPLANTED DUE TO ANATOMY.

  Patient problems: Pericardial Effusion

  MAUDE report 13010037 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE 27MM DEVICE WAS DEPLOYED IN A HEAVILY PECTINATED LAA BUT SAT PROXIMAL TO THE OSTIUM AND WAS UNCOMPRESSED. THE DECISION WAS MADE TO UPSIZE AND A FULL RECAPTURE WAS DONE. AN EFFUSION SWEEP WAS REQUESTED BUT WAS NOT ACHIEVED BY THE IMAGER. THE WAS REMAINED IN THE MID LAA AS THE PIGTAIL EXITED BACK INTO THE LAA. A CONTRAST SHOT WAS TAKEN AND AN EFFUSION WAS OBSERVED IN THE RIGHT VENTRICLE. A 2D ECHO ALSO CONFIRMED THE EFFUSION. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL TAP WAS INITIATED. 1L OF BLOOD WAS REMOVED AND AUTO-TRANSFUSED WHILE 600ML WAS WASTED. THE PATIENT'S BLOOD PRESSURE STABILIZED AND CARDIAC SURGERY TOOK OVER. A STERNOTOMY WAS DONE AND AN ATRICLIP WAS PLACED. THE PATIENT WAS REPORTED TO BE STABLE AND IS EXPECTED TO MAKE A FULL RECOVERY.

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

  MAUDE report 12924217 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT SHEATH KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. DURING DEPLOYMENT OF THE WATCHMAN DEVICE, THE WAS SHEATH WAS TORQUED AND BECAME KINKED. UPON RECAPTURE OF THE DEVICE, THE KINK WORSENED. ADDITIONAL INTERVENTION WAS REQUIRED TO RECAPTURE THE WATCHMAN DEVICE AND REMOVE THE KINKED SHEATH. THE BACK END OF THE DEPLOYMENT KNOB OF THE DEVICE WAS CUT TO REMOVE THE SHEATH AND EXCHANGED FOR A NEW WAS SHEATH. THE WATCHMAN DEVICE WAS RECAPTURED WITH THE USE OF THE NEW WAS BY PULLING THE BACK END OF THE CORE WIRE WHICH PULLED THE DEVICE INTO THE NEW WAS SHEATH. ULTIMATELY THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A WATCHMAN DEVICE AND REPORTED TO HAVE BEEN DISCHARGED THE NEXT DAY WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775176 ↗
• InjuryOct 15, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT UPON REMOVAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. UPON REMOVAL OF THE ANTERIOR WATCHMAN TRUSEAL ACCESS SYSTEM (WAS), A LONG, WHITE FIBER WAS NOTICED ATTACHED TO THE TIP, COMING FROM WITHIN THE INNER LUMEN OF THE SHEATH. THE FIBER WAS FULLY FIXED TO THE DEVICE. THERE WAS NO PATIENT HARM RELATED TO THIS FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639770 ↗
• MalfunctionOct 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT TIP DAMAGE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM AND TRUSEAL ACCESS SYSTEM (WAS) WERE USED. THE PROCEDURE WENT AS PLANNED AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. AFTER THE WAS WAS REMOVED FROM THE BODY THE PHYSICIAN NOTED WHAT APPEARED TO BE A WHITE THREAD THAT WAS A PART OF THE SHEATH PROTRUDING FROM THE DISTAL END OF THE SHEATH. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616129 ↗
• MalfunctionOct 5, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT SHEATH DAMAGE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AN ANTERIOR CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER A PARTIAL RECAPTURE OR THE CLOSURE DEVICE AND REPOSITIONING TO THE PROPER LOCATION, A POLYTETRAFLUOROETHYLENE (PTFE) FILAMENT FROM THE WAS NOTED POST RELEASE CRITERIA CONFIRMATION. THE CLOSURE DEVICE WAS SUCCESSFULLY RELEASED INTO THE LAA. NO PATIENT COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578533 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PSEUDOANEURYSM OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AN ANTERIOR CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA, AND THE PATIENT WAS SCHEDULED FOR DISCHARGE THE FOLLOWING DAY. FIVE DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A PSEUDOANEURYSM NOTED IN THE RIGHT FEMORAL VEIN WITH HEMATOMA. THE PATIENT WAS TREATED WITH A THROMBIN INJECTION ON THE SAME DAY. A REPEAT ULTRASOUND WAS PERFORMED AND THE PATIENT WAS STABLE. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: Hematoma; Pseudoaneurysm

  MAUDE report 12557732 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THROMBUS WAS NOTED ON THE WAS AFTER THE DEVICE WAS DEPLOYED. THE DEVICE MET RELEASE CRITERIA. THE ACTIVATED CLOTTING TIME (ACT) WAS 120 SECONDS DESPITE 10,000 UNITS BEING GIVEN WHICH WAS APPROPRIATE DOSING FOR THE PATIENT'S WEIGHT. THE PHYSICIAN ASPIRATED THE THROMBUS AND IT WAS IDENTIFIED AND FLUSHED OUT OF THE SHEATH AT THE END OF THE CASE. NO COMPLICATIONS WERE NOTED IN RELATION TO THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12423330 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE PROCEDURE START HEPARIN WAS ADMINISTERED. AN ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED GREATER THAN 200 SECONDS THROUGHOUT THE CASE. A TRUSEAL WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER SUCCESSFUL DEVICE PLACEMENT, THE IMAGER SPANNED BACK OVER TO THE SEPTUM AND NOTICED EITHER TISSUE OR CLOT ON THE RIGHT SIDE OF THE SEPTUM UNDER THE WAS SHEATH. RELEASE CRITERIA WAS MET AND THE WAS SHEATH AND WDS WERE REMOVED. THE CLOT OR TISSUE REMAINED AT THE SEPTUM AND DID NOT COME OUT WITH THE SHEATH. THE PATIENT WAS ADMITTED PER STANDARD PROCEDURE AND PLANS TO BE DISCHARGED AS NORMAL WHILE MONITORING FOR ANY CHANGES TO HEMODYNAMICS. THE PATIENT MADE A FULL RECOVERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12252979 ↗
• DeathJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN WAS HAVING A CHALLENGING TIME GETTING VENOUS ACCESS. A 16FR X 13 CM LENGTH NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH WAS PLACED OVER A STANDARD J-WIRE. IT WAS NOTED THIS DID NOT GO SMOOTHLY. THE DILATOR WAS REMOVED AND THEN REINTRODUCED TO REPOSITION THE SHEATH. RADIOGRAPHY SHOWED THE DILATOR WAS NOT IN THE LUMEN OF THE SHEATH. BOTH WERE REMOVED AND REPLACED. THE NON BOSTON SCIENTIFIC INTRODUCER SHEATH DEMONSTRATED A PERFORATION FROM THE DILATOR OF THE TRANSSEPTAL PUNCTURE (TSP) SHEATH. THE NON-BSC GUIDEWIRE BUCKLED/BENT AND THE TSP SHEATH PERFORATED THROUGH THE NON-BSC INTRODUCER SHEATH AND, SUBSEQUENTLY, THROUGH THE FEMORAL VEIN. THE PROCEDURE CONTINUED WITH A NEW 16 FR SHEATH BEING PLACED. THE WATCHMAN PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE, WHILE STILL IN THE ROOM. NO PERICARDIAL EFFUSION WAS PRE

  Patient problems: Hematoma

  MAUDE report 12242638 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS WAS SUSPECTED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ANTERIOR CURVE ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. IT WAS SUSPECTED THAT A THROMBUS FORMED ON THE DISTAL END OF THE WAS ONCE THE DEVICE WAS PLACED INTO THE HEART. ELIQUIS WAS INJECTED INTO THE PATIENT'S HEART TO BREAK UP THE THROMBUS, AND THE PATIENT WAS SUBSEQUENTLY GIVEN HEPARIN. THE CLOSURE DEVICE INITIALLY DID NOT MEET RELEASE CRITERIA, SO IT WAS PARTIALLY RECAPTURED AND REDEPLOYED. POST IMPLANT, IT WAS NOTICED THAT THE PUNCTURE SITE WAS BLEEDING, IN WHICH THE NURSES APPLIED PRESSURE TO THE SITE TO STOP THE BLEEDING. THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT, AND WAS DISCHARGED HOME THE FOLLOWING DAY WITH A PRESSURE DRESSING APPLIED TO THE INCISION SITE. IT WAS ALSO NOTED THAT THE CLOSURE DEVICE WAS SITTING IN THE LAA AT AN ANGLE. THE PATIENT SCHEDULED FOLLOW UP APPOINTMENTS WITH THEIR REGULAR CARDIOLOGIST SET FOR TWO WEEKS POST PROCEDURE AND WITH THE IMPLANTING PHYSICIAN ONE MONTH POST PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 12108832 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VENTRICULAR FIBRILLATION AND HYPOTENSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AFTER TRANSSEPTAL PUNCTURE AND WHEN THE WIRE WAS IN THE LEFT UPPER PULMONARY VEIN (LUPV) WITH THE ANTERIOR CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS), THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) AND THEIR BLOOD PRESSURE DROPPED. THE PATIENT WAS SHOCKED WITH A DEFIBRILLATOR AND THEIR HEART RATE AND BLOOD PRESSURE RESUMED TO NORMAL. AFTER THE WIRE WAS REMOVED AND THE PIGTAIL WAS INSERTED INTO THE WAS, THE WAS WAS ADJUSTED FROM ACROSS THE MITRAL VALVE TO MID LEFT ATRIUM (LA), AND THE PATIENT EXPERIENCED VF AND THEIR BLOOD PRESSURE DROPPED AGAIN. THE PATIENT WAS SHOCKED AGAIN, BUT THE PATIENT WENT INTO VENTRICULAR ARRHYTHMIA AND VENTRICULAR FIBRILLATION BECAUSE THE STAFF DID NOT SYNC THE DEFIBRILLATOR. ONCE THE DEFIBRILLATOR WAS PROPERLY SYNCED, THE PATIENT'S HEART RATE AND BLOOD PRESSURE RESUMED NORMAL AGAIN. A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS USED AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2021.

  Patient problems: Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 12011138 ↗
• MalfunctionJun 1, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL DOUBLE CURVE ACCESS SYSTEM (WAS) WAS INITIALLY ATTEMPTED, BUT EXCHANGED FOR A WATCHMAN TRUSEAL ANTERIOR CURVE ACCESS SYSTEM TO OPTIMIZE A COAXIAL APPROACH INTO THE ANTERIOR LOBE OF THE LAA. WHILE ATTEMPTING TO POSITION A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM(WDS) WITH THE WAS, IT WAS NOTICED ON FLUOROSCOPY THAT THERE WAS A KINK IN THE DISTAL ASPECT OF THE WAS. THE IMPLANTER DECIDED TO CONTINUE WITH ONE MORE ATTEMPT AT AN IMPLANT AS THE DEVICE WAS THOUGHT TO BE STILL IN AN ACCEPTABLE POSITION DESPITE THE KINK. THE CLOSURE DEVICE WAS THEN FULLY RECAPTURED WITH THE WAS AFTER ASSESSMENT SHOWED THE POSITION TO BE UNFAVORABLE IN THE LAA. THERE WERE NO ISSUES WHEN RECAPTURING. THE WAS WAS THEN COMPLETELY REMOVED FROM THE PATIENT ALLOWING FOR A NEW TRANSSEPTAL PUNCTURE IN ORDER TO TRY AND OPTIMIZE THE COAXIAL APPROACH INTO THE LAA WITH A DOUBLE CURVE WAS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912900 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. DURING THE PROCEDURE, THE WAS SHEATH WAS BELIEVED TO HAVE LACERATED THE LEFT ATRIAL APPENDAGE CAUSING A PERICARDIAL EFFUSION. THIS WAS RECOGNIZED AFTER THE WATCHMAN 20MM FLX DEVICE WAS DEPLOYED BUT NOT YET RELEASED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS THEN TAKEN TO SURGERY. DURING SURGERY THEY REMOVED THE WATCHMAN DEVICE AND SURGICALLY CLIPPED THE LEFT ATRIAL APPENDAGE. THE PATIENT REMAINED STABLE THROUGHOUT AND WAS DISCHARGED.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11872832 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AN ANTERIOR CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) CROSSED THE SEPTUM AND IT WAS NOTICED THERE WAS A RIGHT SIDE CLOT FORMING NEAR THE SEPTUM. HEPARIN WAS ADMINISTERED PRIOR TO THE TRANSEPTAL CROSSING AND THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED GREATER THAN 200 THROUGHOUT THE PROCEDURE. THE CLOT WAS RETRIEVED USING THE WAS WHICH WAS BACK UP OVER THE SEPTUM. THE WAS WAS REMOVED FROM THE BODY TO RE-FLUSH AND PREPARE AGAIN. THE WAS WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11872676 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION, CARDIAC ARREST, AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. NO PERICARDIAL EFFUSION WAS NOTED PRE-PROCEDURE. AFTER MULTIPLE ATTEMPTS OF DEPLOYING A 24MM WATCHMAN FLX CLOSURE DEVICE WITH A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS), IT WAS DECIDED TO SWITCH TO AN ANTERIOR CURVE WATCHMAN ACCESS SYSTEM TO OBTAIN MORE ANTERIOR DEPTH. A NEW 24MM WATCHMAN FLX DEVICE WAS ALSO USED. THE WAS WAS ADVANCED INTO THE LAA AND THE UNSHEATHING METHOD WAS USED TO DEPLOY THE DEVICE, HOWEVER, ECHOCARDIOGRAPHY CONFIRMED THE DEVICE WAS DEPLOYED TOO DEEP. A PARTIAL RECAPTURE WAS ATTEMPTED AND UPON PULLING BACK THE SHEATH, A LARGE PERICARDIAL EFFUSION WAS NOTED ON THE ANTERIOR WALL. A PERFORATION WAS CAUSED BY THE WAS GOING THROUGH THE LAA, BUT THIS WAS NOT REALIZED UNTIL AFTER THE RECAPTURE AND REPOSITIONING ATTEMPT FOR THE SECOND DEPLOYMENT WITH THE DEVICE BEING DEPLOYED VIA THE HOLE CREATED BY THE WAS. A CARDIAC TAMPONADE WAS ALSO NOTED. AN UNSUCCESSFUL PERICARDIOCENTESIS WAS ATTEMPTED IN WHICH THE PHYSICIAN PUNCTURED THE PATIENT'S LUNG DURING THIS ATTEMPT. AFTER MULTIPLE ATTEMPTS, A DRAIN WAS S

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 11778636 ↗