WATCHMAN™ TruSeal™ Access System M635TU70020Recalls & reported problems

Summary

The FDA's MAUDE database contains 217 adverse event reports that list this exact device (DI 08714729965718), received between Nov 29, 2018 and Aug 21, 2025 — classified as 11 deaths, 165 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (22 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-2432-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 217 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 3 SERIOUS INJURY EVENTS FOR BLOOD LOSS. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. AGE RANGE: 73 TO 84 YEARS. PATIENT SEX: 1 FEMALE; 2 MALE. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22864624 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR VESSEL PSEUDOANEURYSM. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA

  Patient problems: Pseudoaneurysm

  MAUDE report 22589302 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 3 SERIOUS INJURY EVENTS FOR VESSEL TRAUMA. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. AGE RANGE: 72 TO 78 YEARS. PATIENT SEX: 1 FEMALE; 2 MALE. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS

  Patient problems: Perforation of Vessels

  MAUDE report 22580182 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR UNEXPECTED MEDICAL INTERVENTION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX DAPT CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578244 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 2 SERIOUS INJURY EVENTS FOR VESSEL TRAUMA. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX DAPT CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PRE

  Patient problems: Perforation of Vessels

  MAUDE report 22560052 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THROMBUS PRESENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN SUCCESSFULLY PERFORMED THE TRANSSEPTAL PUNCTURE AND THEN INSERTED THE WAS. THE WAS POSITIONED IN THE LAA OF THE PATIENT AND AN ANGIOGRAM WAS THEN PERFORMED. THE ANGIOGRAM SHOWED THAT THERE WAS A DENSE ECHO CONTRAST THAT WAS ALONG THE COUMADIN RIDGE AT THE OSTIUM OF THE LAA. THE PHYSICIAN BELIEVED THAT THIS WAS A THROMBUS THAT WAS PRESENT IN THE PATIENT. THE DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO CONSEQUENCES AS A RESULT OF THIS EVENT. THE PATIENT IS DOING FINE POST PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17079855 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THROMBUS PRESENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. WHEN THE PHYSICIAN WAS POSITIONING THE WAS IN THE LAA OF THE PATIENT A THROMBUS WAS NOTED TO BE PRESENT. THE PHYSICIAN ASPIRATED THE THROMBUS OUT OF THE PATIENT AND THE PROCEDURE WAS CONTINUED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA AND THEN BEGAN TO INTRODUCE THE WDS. BEFORE INSERTING AND SNAPPING THE WDS TOGETHER WITH THE WAS, THE PHYSICIAN NOTED THAT THERE WAS NO BACK BLEED OCCURRING. THE PHYSICIAN PULLED ALL THE DEVICES BACK INTO THE RIGHT ATRIUM AND NOTED THAT THERE WAS A LARGE THROMBUS PRESENT. ANOTHER ASPIRATION WAS PERFORMED, AND THE WAS WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW WAS. THE CLOSURE DEVICE WAS IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16096135 ↗
• MalfunctionOct 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A SHEATH KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND TWO WATCHMAN TRUSEAL ACCESS SYSTEMS (WAS). FOLLOWING THREE DEPLOYMENTS AND TWO RECAPTURES OF THE CLOSURE DEVICE, A KINK WAS OBSERVED 12CM FROM THE DISTAL TIP OF THE WAS. THE CLOSURE DEVICE WAS FULLY RECAPTURED AND REMOVED AND A GUIDEWIRE WAS ADVANCED INTO THE LEFT ATRIUM. AFTER PLACEMENT OF THE GUIDEWIRE, THE KINKED WAS WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW CLOSURE DEVICE, WDS, AND WAS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607245 ↗
• InjuryOct 5, 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 CLOSURE PROCEDURE WAS PERFORMED. THE WATCHMAN TRUSEAL ACCESS SYSTEM WAS INSERTED THROUGH THE GROIN THROUGH A 16FR SHEATH, AND LIGHT RESISTANCE IN THE GROIN AREA WAS NOTED BUT THE SHEATH WAS ABLE TO PASS AND GO TRANSSEPTAL. THE WATCHMAN DEVICE WAS THEN INSERTED AND ADVANCED WHEN A CLOT ATTACHED TO THE WATCHMAN TRUSEAL ACCESS SYSTEM IN THE RIGHT ATRIUM WAS NOTED. ACTIVATED CLOTTING TIME AT THIS TIME WAS 284 SECONDS. THE WATCHMAN WAS IMPLANTED SINCE THE CLOT WAS RIGHT SIDED. THE PROCEDURE WAS SUCCESSFUL WITH ONE DEPLOYMENT. AFTER DEPLOYMENT, THE WATCHMAN DELIVERY SYSTEM WAS REMOVED BUT THE WATCHMAN SHEATH WAS LEFT IN PLACE SO THAT THEY DID NOT DISLODGE THE CLOT. THE PHYSICIAN THEN GAINED ADDITIONAL GROIN ACCESS, WENT UP THE INFERIOR VENA CAVA (IVC) INTO THE RIGHT ATRIUM WITH A NON-BOSTON SCIENTIFIC SHEATH AND UNKNOWN CATHETER AND PERFORMED MANUAL ASPIRATION OF THE CLOT AND RETRIEVED IT OFF OF THE WATCHMAN SHEATH. THERE WAS NO RESIDUAL CLOT VISUALIZED AFTER ASPIRATION, SO THE WATCHMAN SHEATH WAS THEN REMOVED FROM THE BODY. NO FURTHER ACTION WAS REQUIRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15544952 ↗
• InjurySep 26, 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 CLOSURE PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THERE WAS CLOT IN THE WATCHMAN TRUSEAL ACCESS SYSTEM. THE CLOT WAS ASPIRATED THROUGH THE ACCESS SYSTEM AND THE ACCESS SYSTEM WAS REMOVED. THIS OCCURRED PRIOR TO THE USE OF A WATCHMAN FLX LAA CLOSURE DEVICE AND DELIVERY SYSTEM. A NEW ACCESS SYSTEM WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL FOR MONITORING AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15486827 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS ATTEMPTED USING A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). DURING THE TRANSSEPTAL PUNCTURE AND THE WAS CROSSING THE INTERATRIAL SEPTUM A PERICARDIAL EFFUSION (PE) WAS DISCOVERED. THE PE INCREASED IN SIZE AND THE PATIENT BECAME HYPOTENSIVE. AFTER A PERICARDIAL DRAIN WAS PLACED, BLOOD WAS RECIRCULATED TO THE PATIENT. THE ACTIVATED COAGULATION TIME (ACT) OF THE PATIENT WAS 368 SECONDS AT THIS POINT IN THE PROCEDURE. 720ML OF BLOOD WAS DRAINED AND PROTAMINE WAS ADMINISTERED. FOLLOWING ADMINISTRATION OF PROTAMINE AN ADDITIONAL 180ML OF BLOOD WAS DRAINED. AFTER THIS ADDITIONAL BLOOD WAS DRAINED THE ACT OF THE PATIENT WAS 116 SECONDS. A FURTHER 10ML OF BLOOD WAS DRAINED AND THE LAA CLOSURE PROCEDURE WAS ABORTED. AT AN UNSPECIFIED TIME FOLLOWING THE PROCEDURE A PERICARDIAL WINDOW WAS PLACED. SIX DAYS POST INDEX PROCEDURE THE PATIENT FULLY RECOVERED AND WAS DISCHARGED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 15330063 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). INTRA CARDIAC ECHOCARDIOGRAM (ICE) REVEALED A CIRCUMFERENTIAL PERICARDIAL EFFUSION LOCATED AROUND THE LAA PRE PROCEDURE. THE WAS WAS ADVANCED AND USED TO DILATE THE INTERATRIAL SEPTUM BEFORE CROSSING TO THE LEFT SIDE OF THE HEART. THE ICE CATHETER WAS USED IN AN ATTEMPT TO LOCATE THE POSITION OF THE TRANSEPTAL PUNCTURE WIRE AND WAS AS NEITHER WERE VISIBLE IN THEIR INTENDED LOCATIONS. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL TAP WAS PERFORMED. APPROXIMATELY 1600CC OF BLOOD WAS REMOVED FROM THE PATIENT. A BLOOD SATURATION TEST DETERMINED THE BLOOD ORIGINATED FROM THE LEFT SIDE OF THE HEART. PROTAMINE WAS ADMINISTERED AND THE PATIENT UNDERWENT MONITORING UNTIL THE PERICARDIAL EFFUSION STABILIZED. THE LAA CLOSURE PROCEDURE WAS ABORTED TO BE RESCHEDULED IN THE FUTURE. DURING PHYSICIAN MONITORING, THE PATIENT BECAME STABLE. THREE DAYS POST INDEX PROCEDURE THE PATIENT WAS DISCHARGED.

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

  MAUDE report 15321140 ↗
• InjuryAug 24, 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. 7000 UNITS OF HEPARIN WERE GIVEN. DURING FORMATION OF THE FLEX BALL INSIDE THE LAA IT WAS NOTICED THAT A CLOT WAS FORMING ON THE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). THE WATCHMAN DELIVERY SYSTEM WAS PULLED BACK AND THEN IT WAS ATTEMPTED TO ASPIRATE FROM THE WAS, WHICH DID NOT WORK. THEN THE WAS WAS PULLED BACK INTO THE RIGHT ATRIUM AND OUT OF THE BODY TAKING THE CLOT WITH IT. AT THIS POINT THE ACTIVATED CLOTTING TIME (ACT) WAS 239 SECONDS AND ANOTHER 3000 UNITS OF HEPARIN WERE GIVEN. IT WAS THEN NOTICED THERE WAS A CLOT ON THE SEPTUM IN THE RIGHT ATRIUM WHEN CROSSING BACK ACROSS THE SEPTUM BUT IT WAS DECIDED TO PROCEED SINCE IT WAS ON THE RIGHT SIDE. IT WAS THEN NOTICED THAT THE CLOT WAS NO LONGER THERE. THE WATCHMAN DEVICE WAS SUCCESSFULLY IMPLANTED MEETING ANCHORING CRITERIA. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15284707 ↗
• InjuryAug 10, 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 FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). FOLLOWING DEPLOYMENT OF THE CLOSURE DEVICE, A THROMBUS DEVELOPED ON THE WAS AND WAS OBSERVED AT THE INTERCHANGE BETWEEN THE WAS SHEATH AND THE DELIVERY SYSTEM. THE ACTIVATED COAGULATION TIME AT THIS POINT IN THE PROCEDURE WAS 111 SECONDS. THE THROMBUS WAS ASPIRATED INTO THE WAS SHEATH AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15202523 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. TRANS-SEPTAL PUNCTURE (TSP) WAS PERFORMED AND A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS INSERTED. AFTER CROSSING THE SEPTUM WITH THE WAS, A PIGTAIL CATHETER WAS INSERTED AND THE WAS MANIPULATED. A PE WAS NOTED ON THE LEFT SIDE OF THE HEART VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). IT IS UNKNOWN IF THE TSP OR THE WAS CAUSED THE PE. A PERICARDIOCENTESIS WAS PERFORMED AND 900CC OF FLUID WAS REMOVED. THE PATIENT IS STABLE AND STAYING OVERNIGHT IN THE HOSPITAL. THE PATIENT IS EXPECTED TO RE-ATTEMPT LAA CLOSURE AT A FUTURE DATE.

  Patient problems: Pericardial Effusion

  MAUDE report 15179960 ↗
• DeathAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA. THERE WERE NO COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE. WHILE IN THE RECOVERY AREA THE PATIENT DEVELOPED ABDOMINAL PAIN. THE PHYSICIAN DETERMINED THE CAUSE OF THE PAIN TO BE BLEEDING AT THE GROIN ACCESS SITE WITH ABDOMINAL SWELLING. THE PATIENT DECOMPENSATED AND REQUIRED CARDIOPULMONARY RESUSCITATION. IN ADDITION THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT DID NOT RECOVER FROM THESE EVENTS AND DIED THE SAME DAY. THE PATIENT DIED FROM HEMORRHAGIC SHOCK.

  Patient problems: Hematoma

  MAUDE report 15148058 ↗
• InjuryJul 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. DURING THE CASE HEPARIN WAS GIVEN JUST BEFORE THE TRANSSEPTAL PUNCTURE (TSP). THE INITIAL ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 300 SECONDS. DURING THE EXCHANGE FOR THE WATCHMAN ACCESS SYSTEM (WAS), THE PHYSICIAN ACCIDENTALLY LOST TSP ACCESS AND FELL BACK TO THE RIGHT SIDE. THE WAS REMOVED FROM THE PATIENT. A SMALL THROMBUS ATTACHED TO THE FOSSA ON THE RIGHT SIDE WAS NOTICED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE TSP SHEATH WAS INSERTED AGAIN AND ASPIRATED THE CLOT OUT, AND IT WAS MITIGATED. THE WAS SHEATH WAS FLUSHED AND CONTINUED THE CASE. NO OTHER PATIENT COMPLICATIONS WERE KNOWN OR SEEN DURING THIS CASE. THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15124781 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PLEURAL EFFUSION. 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. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THE PHYSICIAN PERFORMED A FINAL EFFUSION SWEEP VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. THE IMAGING SHOWED THAT THERE WAS A 1CM RIGHT VENTRICLE PLEURAL EFFUSION. THE EFFUSION WAS OBSERVED FOR 10-15 MINUTES BEFORE THE DECISION WAS MADE TO LEAVE IT AND REPEAT ANOTHER ECHOCARDIOGRAM IMAGE ONE HOUR POST PROCEDURE. THERE WERE NO CHANGES TO THE PATIENTS VITAL SIGN AND NO INTERVENTION WAS EVER NEEDED FOR THE EFFUSION. THE PATIENT WAS DISCHARGED THE NEXT DAY AS PLANNED DOING FINE FOLLOWING THESE EVENTS.

  Patient problems: Pleural Effusion

  MAUDE report 15111807 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION. PRIOR TO THE START OF THE PROCEDURE IT WAS NOTED THAT THE PATIENT HAD A 1.3CM SIZED PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. DURING THE PROCEDURE THE PATIENTS BLOOD PRESSURE HAD DROPPED SO THE PHYSICIAN WANTED TO PERFORM A PERICARDIOCENTESIS POST PROCEDURE. IT WAS ALSO NOTED THAT THE RIGHT SIDED PERICARDIAL EFFUSION HAD A SLIGHT INCREASE IN SIZE. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND DRAINED 300 TO 500CC OF FLUID FROM THE PATIENT. FOLLOWING THIS TREATMENT THE EFFUSION WAS RESOLVED. THE PATIENT MADE A FULL RECOVERY AND WAS DISCHARGED THE NEXT DAY AS PLANNED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 15105811 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED. FOLLOWING THE COMPLETION OF THE PVI, A DOUBLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS PLACED IN THE GROIN. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS MOVED, AND THE VASOPRESSOR LEVELS INCREASED FROM 0.08 TO 0.16 WITHIN 30 MINUTES. AN EFFUSION CHECK WAS PERFORMED WITH THE ICE CATHETER, AND A PERICARDIAL EFFUSION WAS NOTED. THE PERICARDIAL EFFUSION PROGRESSED TO A CARDIAC TAMPONADE. THE PROCEDURE WAS ABORTED, AND A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE EFFUSION. THE PATIENT WAS TRANSFERRED TO INPATIENT STATUS AND FULLY RECOVERED FROM THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 14915513 ↗
• InjuryJun 30, 2022Adverse 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. HEPARIN HAD BEEN ADMINISTERED AND THE ACTIVATED CLOTTING TIME (ACT) WAS 232 SECONDS AFTER THE TRANSEPTAL PUNCTURE. A DOUBLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM WAS ADVANCED INTO THE PATIENT'S ANATOMY. UPON LOOKING AT THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING, A THROMBUS WAS NOTED ON THE TIP OF THE ACCESS SYSTEM. THE THROMBUS WAS ASPIRATED INTO THE ACCESS SYSTEM AND REMOVED FROM THE PATIENT. A NEW SINGLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM WAS USED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14878975 ↗
• InjuryJun 29, 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 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN WAS POSITIONING THE WAS IN THE LAA WHEN IT WAS NOTED THERE WAS A SMALL HYPERMOBILE THROMBUS THAT WAS PRESENT ON THE PIGTAIL CATHETER. ANOTHER 2000 UNITS OF HEPARIN WERE ADMINISTERED TO THE PATIENT TO HELP TREAT THE THROMBUS. IN ADDITION BOTH THE PIGTAIL CATHETER AND WAS WERE USED TO ASPIRATE THE THROMBUS. AFTER FEELING THAT THE ASPIRATION WAS SUFFICIENT THE PROCEDURE WAS CONTINUED WITH THE WAS BEING POSITIONED SUCCESSFULLY IN THE LAA OF THE PATIENT. THE PHYSICIAN INSERTED THE WDS INTO THE WAS, BUT PRIOR TO SNAPPING THE DEVICES TOGETHER ANOTHER NEW LARGER HYPERMOBILE THROMBUS WAS NOTED IN THE ANTERIOR AND SUPERIOR LOBE OF THE LAA. THE DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE AND DEPLOY THE CLOSURE DEVICE. ALL THE RELEASE CRITERIA WAS MET AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO OTHER COMPLICATIONS THAT OCCURRED AND NO OTHER INTERVENTION OR TREATMENT WAS PERFORMED. THE PATIE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14856789 ↗
• InjuryJun 21, 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. INITIAL INTRACARDIAC ECHOCARDIOGRAM (ICE) ASSESSMENT OBTAINED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT OF THE LAA REVEALED NO OBVIOUS THROMBUS. TRANS-SEPTAL CROSSING WAS PERFORMED AND TWO WATCHMAN TRUSEAL ACCESS SYSTEMS (WAS) WERE USED, A SINGLE CURVE AND A DOUBLE CURVE. THE SINGLE CURVE WAS USED FOR ICE CATHETER ADVANCEMENT INTO THE LEFT ATRIUM (LA) AND THE DOUBLE CURVE WAS USED FOR THE PIGTAIL ADVANCEMENT INTO THE LAA. CONTRAST ASSESSMENT WAS PERFORMED TO CONFIRM LOCATION. THE ICE CATHETER WAS THEN POSITIONED TO OPTIMIZE VISUALIZATION OF THE PIGTAIL IN THE LAA WHICH THEN REVEALED A THROMBUS IN THE LAA SURROUNDING THE PIGTAIL AND THE DISTAL SHEATH OF THE DOUBLE CURVE WAS. A 27MM WATCHMAN FLX LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS ADVANCED WITH PLANS TO TRAP THE THROMBUS IN THE LAA BEHIND THE CLOSURE DEVICE. THREE ATTEMPTS WERE MADE TO IMPLANT THE CLOSURE DEVICE, HOWEVER ATTEMPTS WERE UNSUCCESSFUL AS THE POSITIONING WAS NOT OPTIMAL AND DEVICE WAS PARTIALLY RECAPTURED. THE PHYSICIANS THEN NOTED A SECOND MOBILE THROMBUS OUTSIDE THE LAA. THE CLOSURE DEVICE WAS FULLY

  Patient problems: Confusion/ Disorientation; Hematoma; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 14754587 ↗
• DeathJun 17, 2022Adverse 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 PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND WATCHMAN ACCESS SYSTEM (WAS). AT AN UNSPECIFIED POINT IN THE PROCEDURE THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT THE PATIENT DIED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 14732573 ↗
• DeathJun 14, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) WAS BEING PERFORMED. RIGHT FEMORAL ACCESS WAS GAINED AND TRANS-SEPTAL PUNCTURE (TSP) WAS PERFORMED WITH DIFFICULTY. THE TSP SYSTEM WAS REMOVED AND AN ANTERIOR CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS INSERTED. THERE WAS DIFFICULTY MANEUVERING THE ANTERIOR CURVE WAS, WHICH THE PHYSICIAN BELIEVED WAS DUE TO THE TSP CROSSING. THE ANTERIOR CURVE WAS REMOVED AND TSP WAS RE-PERFORMED. THE TSP SYSTEM WAS REMOVED AND A DOUBLE CURVE WAS INSERTED. AGAIN, THERE WAS DIFFICULTY MANEUVERING THE DOUBLE CURVE WAS, WHICH THE PHYSICIAN BELIEVED WAS CAUSED BY THE TSP CROSSING. THE DOUBLE CURVE WAS REMOVED AND AN EFFUSION SWEEP WAS PERFORMED WHICH REVEALED A PE. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT WAS ADMINISTERED A PLATELET INFUSION, AND TAKEN TO THE INTENSIVE CARE UNIT (ICU). LATER THAT SAME DAY THE PATIENT WAS TRANSFERRED TO SURGERY TO MANAGE THE BLEEDING. THE PATIENT DID NOT SURVIVE SURGICAL INTERVENTION. THE OFFICIAL CAUSE OF DEATH WAS UNCONTROLLED BLEEDING.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 14690693 ↗