WATCHMAN TruSeal Access SystemRecalls & reported problems across all models

We found 3 models of WATCHMAN TruSeal Access System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 288 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2018 and Aug 21, 2025 — classified as 12 deaths, 222 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (27 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

WATCHMAN TruSeal Access System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 29, 2025Open, 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 ↗

2. Jul 29, 2025Open, 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 ↗

3. Jul 29, 2025Open, 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-2431-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported WATCHMAN TruSeal Access System problems

WATCHMAN TruSeal Access System models

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

• WATCHMAN™ TruSeal™ Access System M635TU70020

  Catheter, percutaneous
  1 recall11 deaths217 reports
• WATCHMAN™ TruSeal™ Access System M635TU70040

  Catheter, percutaneous
  1 recall1 death50 reports
• WATCHMAN™ TruSeal™ Access System M635TU70010

  Catheter, percutaneous
  1 recall21 reports

Recent WATCHMAN TruSeal Access System adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. 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. THE PHYSICIAN POSITIONED THE WAS AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED IN THE PATIENT AND SUCCESSFULLY IMPLANTED IN THE LAA. POST CLOSURE DEVICE RELEASE IT WAS DISCOVERED THAT THERE WAS A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE AROUND THE RIGHT VENTRICLE. THE PATIENT WAS GIVEN PROTAMINE POST PROCEDURE AND WAS BROUGHT TO RECOVERY. THE PATIENT WAS THEN BROUGHT BACK TO THE LAB SO THE PHYSICIAN COULD PERFORM A PERICARDIOCENTESIS. THE PHYSICIAN BELIEVES THAT THE PERICARDIAL EFFUSION WAS A RESULT OF THE WAS DURING THE TRANSSEPTAL INSERTION. THE PATIENT IS RECOVERING AND EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 17493461 ↗
• 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 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 ↗

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