WATCHMAN Access SystemRecalls & reported problems across all models

We found 3 models of WATCHMAN Access System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 805 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Feb 26, 2026 — classified as 33 deaths, 607 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (70 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. 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

Most reported WATCHMAN Access System problems

WATCHMAN Access System models

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

• WATCHMAN® Access System M635TU20060

  System, appendage closure, left atrial
  27 deaths634 reports
• WATCHMAN® Access System M635TU40060

  System, appendage closure, left atrial
  4 deaths111 reports
• WATCHMAN® Access System M635TU10060

  System, appendage closure, left atrial
  2 deaths60 reports

Recent WATCHMAN Access System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE WATCHMAN DOUBLE CURVE ACCESS SYSTEM (WAS) AND VERSACROSS CONNECT (VCC) SYSTEM WERE PREPARED FOR TRANSSEPTAL PUNCTURE (TSP). A HALF DOSE OF HEPARIN WAS ADMINISTERED PRIOR TO TSP, AND THE REMAINING HEPARIN WAS ADMINISTERED AFTER LEFT ATRIAL ACCESS WAS OBTAINED. TSP WAS PERFORMED AND WHILE REMOVING THE VCC DILATOR, MOBILE THROMBUS MATERIAL WAS OBSERVED ON TEE AT THE DISTAL END OF THE WAS WITHIN THE LEFT ATRIUM. THE MATERIAL WAS ASPIRATED BACK INTO THE WAS, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. UPON FLUSHING THE WAS ON THE BACK TABLE, ADDITIONAL CLOT MATERIAL WAS IDENTIFIED WITHIN THE SHEATH. THE PHYSICIAN ELECTED TO CANCEL THE PROCEDURE DUE TO CLOT FORMATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24454975 ↗
• InjuryAug 21, 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 TO

  Patient problems: Pseudoaneurysm

  MAUDE report 22865943 ↗
• 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 HEMATOMA. 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: 69 TO 78 YEARSPATIENT SEX: 2 FEMALE; 1 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 LIMITATION

  Patient problems: Hematoma

  MAUDE report 22864851 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR SURGICAL 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 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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864625 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT HAD BEEN TAKING ELIQUIS PRE-PROCEDURE. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS BEING PERFORMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING. GROIN ACCESS WAS OBTAINED, AND HEPARIN WAS GIVEN. THE FIRST ACTIVATED CLOTTING TIME (ACT) RESULT WAS THERAPEUTIC. A VERSACROSS CONNECT (VCC) KIT WAS SELECTED FOR USE. A WATCHMAN DOUBLE CURVE ACCESS SYSTEM (WAS) WAS INSERTED WITH THE VCC KIT. DURING TRANSSEPTAL PUNCTURE (TSP), A MOBILE THROMBUS WAS NOTED ON THE FOSSA OVALIS / SEPTUM GOING THROUGH A PATENT FORAMEN OVALE (PFO) AND IT SHOWED ON BOTH THE LEFT ATRIUM AND RIGHT ATRIUM. ASPIRATION OF THE THROMBUS WAS PERFORMED. A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PROCEDURE WAS CONCLUDED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22738076 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 5 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: 71 TO (B)(6) YEARS. PATIENT SEX: 4 FEMALE; 1 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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22590411 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 2 SERIOUS INJURY EVENTS FOR RETROPERITONEAL HEMORRHAGE. 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

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 22589488 ↗
• 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 HEMATOMA. 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 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 TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY

  Patient problems: Hematoma

  MAUDE report 22578325 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE OPTION CLINICAL STUDY (WATCHMAN GROUP) ON (B)(6) 2020 WITH PATIENT IDENTIFIER (B)(6) AND THE PROCEDURE WAS PERFORMED 20 DAYS LATER. IT WAS REPORTED THAT WORSENING ATRIAL SEPTAL DEFECT RESULTING IN FATIGUE AND SHORTNESS OF BREATH OCCURRED. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) ASSESSMENT ON (B)(6) 2020 REVEALED A LEFT VENTRICULAR EJECTION FRACTION OF 60%. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT ALSO REVEALED ONE LAA LOBE WITH A WINDSOCK MORPHOLOGY WITH AN OSTIUM DIAMETER OF 30.6MM AND LAA LENGTH OF 27.3MM. A DOUBLE CURVE WATCHMAN ACCESS SHEATH (WAS) (LOT # 25187139) WAS INTRODUCED AND DEPLOYMENT OF A 35 MM WATCHMAN FLX DELIVERY SYSTEM (WDS) WAS ATTEMPTED. COMPRESSION WAS SUBOPTIMAL AND THE DEVICE WAS REMOVED. ANOTHER 31 MM WDS WAS ALSO INTRODUCED AND WAS NOT RELEASED ALSO DUE TO SUBOPTIMAL COMPRESSION. THE WAS WAS CONSIDERED TOO HIGH TO ALLOW FOR DEPLOYMENT AND WAS REMOVED. A TRANSSEPTAL PUNCTURE WAS DONE AGAIN AT A SLIGHTLY MORE INFERIOR POSITION WITH THE HELP OF ANOTHER ANTERIOR CURVE WAS (LOT #25228986). THE SUBJECT UNDERWENT SUCCESSFUL PLACEMENT OF A 35 MM WATCHMAN FLX CLOSURE DEVICE WITH COMPLETE LAA SEAL. THE PATIENT WAS DISCHARGED HOME T

  Patient problems: Dyspnea; Fatigue

  MAUDE report 17899964 ↗
• MalfunctionMay 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A SHEATH KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. UPON ASSESSING THE LAA WITH THE WAS, A KINK OCCURRED ON THE DISTAL END. THE DECISION WAS MADE TO CONTINUE USING THAT WAS AND NOT EXCHANGE IT. THE WDS WAS ADVANCED INTO THE WAS AND THE CLOSURE DEVICE WAS DEPLOYED. IMMEDIATELY FOLLOWING DEVICE DEPLOYMENT, THE DEVICE PERFORATED THE LAA LEADING TO A PERICARDIAL EFFUSION. THERE WAS NO INITIAL HEMODYNAMIC COMPROMISE NOTED FROM THE PERFORATION. THE DEVICE WAS LEFT IN PLACE AND IMPLANTED TO AVOID CAUSING A TEAR OR HOLE IN THE LAA AND TO ALLOW THE PERICARDIAL EFFUSION TO BE CONTROLLED. PROTAMINE WAS GIVEN AND A PERICARDIOCENTESIS WAS ATTEMPTED. A PNEUMOTHORAX OCCURRED DUE TO THE ATTEMPTED AND FAILED PERICARDIOCENTESIS AND A CHEST TUBE WAS INSERTED. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION WITH THE CHEST TUBE IN PLACE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887240 ↗
• InjuryMay 13, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE ACTIVATED CLOTTING TIME (ACT) WAS IN THE RANGE OF 200 TO 300 SECONDS AND THE PATIENT WAS ON WARFARIN AND STOPPED TAKING THIS TWO DAYS PRIOR TO THE PROCEDURE. THE IMPLANTING TEAM INITIALLY HAD DIFFICULTY ENGAGING THE SEPTUM AND UPON CROSSING OF THE SEPTUM, THE TEAM HAD DIFFICULTY EXCHANGING TO A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) AS THE SEPTUM WAS REPORTED TO BE TOUGH. AFTER REPEATED ATTEMPTS WITH THE DILATOR, THE SEPTUM WAS SUCCESSFULLY CROSSED. UPON REMOVAL OF THE NON-BOSTON SCIENTIFIC WIRE, THROMBUS WAS IDENTIFIED VIA ECHOCARDIOGRAPHY ON THE SEPTUM AT THE SEPTAL CROSSING IN THE RIGHT ATRIUM AND ON THE TIP OF THE WAS. THE THROMBUS WAS REPORTED TO BE MOBILE. AN ATTEMPT WAS MADE TO ASPIRATE THE THROMBUS, HOWEVER, THIS WAS UNSUCCESSFUL. THE WAS PULLED BACK INTO THE RIGHT ATRIUM AND OUT OF THE BODY. ONCE REMOVED FROM THE BODY, AN ORGANIZED THROMBUS WAS IDENTIFIED ON THE OUTER SHEATH OF THE WAS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS EXTUBATED. THERE WERE NO COGNITIVE DEFECTS AND THE PATIENT WAS NEUROLOGICALLY INTACT. THE PATIENT WAS DISCHARGED HOME THE SAME

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11822770 ↗
• InjuryApr 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A KINK AND PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM AND TWO WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEMS WERE USED. A PERICARDIAL EFFUSION WAS NOTED AT BASELINE AROUND THE RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). IT WAS NOTED THAT THE BASELINE EFFUSION AROUND THE RA HAD GROWN SLIGHTLY AFTER A VERY DIFFICULT TRANSEPTAL PUNCTURE, BUT THE PATIENT WAS STABLE. A 33MM WATCHMAN LAA CLOSURE DEVICE WAS DEPLOYED, BUT WAS PROXIMAL. THEREFORE, A FULL RECAPTURE WAS PERFORMED AND EFFUSION WAS NOTED TO BE STABLE. A 30MM WATCHMAN LAA CLOSURE DEVICE WAS ATTEMPTED NEXT. THE DEVICE LANDED SLIGHTLY DEEP AND A PARTIAL RECAPTURE WAS PERFORMED. IT WAS NOTED THAT THE DEVICE WAS HOOKED ON THE APPENDAGE WALL. DURING A RECAPTURE ATTEMPT THE ACCESS SYSTEM KINKED AT THE DARK-LIGHT BLUE TRANSITION AND THERE WAS A STRUGGLE TO PULL THE FEET OF THE DEVICE INTO THE ACCESS SYSTEM DUE TO THE LARGE KINK. A KINK WAS ALSO NOTED IN THE DELIVERY SYSTEM. PROACTIVELY, A PERICARDIAL DRAIN WAS PUT IN AND 100CCS WAS DRAINED. THE 30MM DEVICE WAS SUCCESSFULLY RECAPTURED AND THE EFFUSION WAS NOTED TO BE STABLE. ANOTHER ACCES

  Patient problems: Pericardial Effusion

  MAUDE report 11749432 ↗
• InjuryMar 23, 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 DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE WAS WAS PLACED ACROSS THE SEPTUM, THEY NOTICED SOME OBJECT ON THE TIP OF THE SHEATH OR THE NON-BOSTON SCIENTIFIC GUIDEWIRE THAT WAS IN THE LEFT ATRIUM. THE ACTIVATED CLOTTING TIME (ACT) WAS IN THE THERAPEUTIC RANGE AROUND 250 SECONDS. ASPIRATION WAS PERFORMED WITH A SYRINGE ON THE WAS. THEY DID NOT SEE ANY CHANGE ON ECHO AND THE FOREIGN BODY WAS STILL PRESENT. THE GUIDEWIRE WAS REMOVED AND AS THEY RETRACTED THE GUIDEWIRE THEY ASPIRATED THROUGH THE WAS. AT THE END OF THIS MANEUVER THE FOREIGN BODY WAS NOT SEEN AND THE PROCEDURE CONTINUED. THE DEVICE WAS SUCCESSFULLY IMPLANTED AND NO FURTHER INTERVENTIONS WERE NEEDED. THE ACT REMAINED ABOVE 300 SECONDS AFTER THE FOREIGN BODY WAS SEEN. THE PATIENT WAS CHECKED FOR ANY SIGNS OF STROKE OR TRANSIENT ISCHEMIC ATTACK AND NONE WERE SEEN OR NOTED BY THE PHYSICIAN. THE PATIENT IS DOING WELL WITH NO FURTHER ISSUES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11556343 ↗
• MalfunctionMar 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A SHEATH KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AN ANTERIOR CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER A FULL RECAPTURE OF THE DEVICE, A SHEATH EXCHANGE WAS NEEDED SINCE THERE WAS A KINK NOTED IN THE WAS AT THE GROIN. THE SHEATH WAS INSERTED THROUGH A 16FR NON-BOSTON SCIENTIFIC SHORT SHEATH. THE GUIDEWIRE USED TO SAVE THE TRANSSEPTAL ACCESS AND TO BE ABLE TO GO UP WITH A NEW WAS AN 0.035 INCH NON-BOSTON SCIENTIFIC GUIDEWIRE. A PERICARDIAL EFFUSION WAS NOTED AT THIS TIME. THERE WAS A LOT OF MOVEMENT WITH THE GUIDEWIRE TO TRY AND REPOSITION BACK IN THE LEFT UPPER PULMONARY VEIN. THE PATIENT WAS STABLE AND THE CASE CONTINUED. A 24MM DEVICE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS KEPT ON THE CATH LAB TABLE TO WATCH THE EFFUSION AND MAKE SURE VITALS WERE STABLE. AS SOON AS THE 24MM WAS RELEASED, PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN. ACTIVATED CLOTTING TIME (ACT) DURING THE CASE WAS 332 SECONDS. AFTER 15 MINUTES THE EFFUSION WAS MEASURED AGAIN AND IT WAS UNCHANGED AT 1.2CM. NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476311 ↗
• InjuryFeb 4, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BACK BLEED DID NOT OCCUR AND THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT HAD A THROMBUS ON THE TRANSSEPTAL GUIDEWIRE AND SHEATH, SO BOTH WERE REMOVED AND PRESSURE WAS HELD ON THE RIGHT FEMORAL VEIN. A SMALL HEMATOMA WAS NOTED SO PRESSURE WAS HELD. THE LEFT FEMORAL VEIN WAS USED, AND THE TRANSSEPTAL WAS SUCCESSFUL. A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE 27MM DEVICE WAS UNDER COMPRESSED, SO A 30MM DEVICE WAS PREPPED. THE WAS SHEATH WAS GETTING AIR IN THE SHEATH AND WOULD NOT BLEED BACK SO A NEW DOUBLE CURVE WAS PLACED. THE 30MM DEVICE WAS INSERTED AND IT WAS NOTICED THE PATIENT HAD A DROP IN BLOOD PRESSURE (70 SYSTOLIC) AND THE SHEATH WAS STILL WAS NOT BLEEDING BACK. A LARGE HEMATOMA WAS FOUND IN THE RIGHT GROIN. THE 30MM DEVICE WAS REMOVED, AND THE SHEATH WAS BROUGHT TO THE RIGHT SIDE AND PROTAMINE WAS GIVEN. PRESSURE WAS HELD TO THE GROIN, AND 2 UNITS OF BLOOD WERE GIVEN. THE ESTIMATED BLOOD LOSS FROM THE PROCEDURE WAS 500-600CC AND ALL BLOOD LOSS WAS FEMORAL. THE PATIENT WAS STABLE TWO HOURS POST-PROCEDU

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11282393 ↗

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