WATCHMAN® Access System M635TU40060Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 08714729838210), received between Nov 15, 2016 and Oct 9, 2023 — classified as 4 deaths, 80 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (P130013); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryDec 8, 2020Adverse 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. HEPARIN WAS ADMINISTERED. ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE 290 AFTER TRANSSEPTAL PUNCTURE. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND THREE WATCHMAN LAA CLOSURE DEVICES WERE ATTEMPTED; HOWEVER, THE PATIENT ANATOMY WAS MORE SUITABLE FOR THE NEXT GENERATION WATCHMAN FLX LAA CLOSURE DEVICE, SO THE PROCEDURE WAS ABORTED. AFTER THE WAS PULLED BACK ACROSS THE SEPTUM AND OUT OF THE BODY, A CLOT WAS NOTED AT THE TRANSSEPTAL PUNCTURE SITE ON THE RIGHT ATRIAL SIDE VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. NO CLOT WAS NOTED ON THE LEFT SIDE AND THE PATIENT DID NOT WAKE UP WITH ANY NEURO CHANGES.

  Patient problems: Thrombosis

  MAUDE report 10970185 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION AND TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AFTER TRANSSEPTAL PUNCTURE, A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS INSERTED WITH A PIGTAIL CATHETER. THE LEFT ATRIAL APPENDAGE (LAA) WAS UNABLE TO BE ACCESSED, SO THE DOUBLE CURVE AND PIGTAIL WERE REMOVED. THE PIGTAIL CATHETER AND AN ANTERIOR CURVE WAS WERE INSERTED; HOWEVER, THE ANTERIOR CURVE WAS KINKED, SO THE ANTERIOR CURVE WAS AND PIGTAIL WERE REMOVED. A NEW TRANSSEPTAL PUNCTURE WAS PERFORMED TO BETTER ALIGN WITH THE LAA. A NEW ANTERIOR CURVE WAS AND PIGTAIL WERE INSERTED. GOOD POSITION FOR DEPLOYMENT WAS ACHIEVED, AND A WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS INSERTED AND THE CLOSURE DEVICE WAS DEPLOYED. THE POSITION DID NOT MEET RELEASE CRITERIA SO THE DEVICE WAS RECAPTURED. THE PIGTAIL WAS REINSERTED AND GOOD POSITION WAS ACHIEVED AGAIN. A NEW WATCHMAN CLOSURE DEVICE WAS INSERTED, BUT THE POSITION WAS LOST AND THE DEVICE WAS REMOVED AND REPLACED WITH A PIGTAIL. THE PIGTAIL CATHETER WAS USED TO TAKE ANOTHER CONTRAST INJECTION AND SHOWED NO SIGNS OF PERFORATION. MORE MANIPULATION WAS ATTEMPTED TO GET TO A DESIRABLE

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 10943320 ↗
• InjuryNov 10, 2020Adverse 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 BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED. DURING THE PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED A SMALL CLOT FORMED AT THE END OF THE WAS AND THE CLOT WAS ASPIRATED AND REMOVED. AN ACTIVATED CLOTTING TIME OF 400 WAS NOTED. THE PROCEDURE WAS ABORTED AND THE PATIENT REMAINED STABLE AND WAS DISCHARGED.

  Patient problems: Thrombosis

  MAUDE report 10815826 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT HYPOTENSION AND BLEEDING OCCURRED. ON (B)(6) 2020, PRIOR TO THE LEFT ATRIAL APPENDAGE (LAA) CLOSURE INDEX PROCEDURE, THE SUBJECT WAS STARTED ON ASPIRIN AND POST IMPLANT THE SUBJECT WAS STARTED ON WARFARIN/VKA. THE DOUBLE CURVE WATCHMAN ACCESS SHEATH (WAS) 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 DOUBLE CURVE WAS. THE SUBJECT UNDERWENT SUCCESSFUL PLACEMENT OF A 35 MM WATCHMAN FLX CLOSURE DEVICE WITH COMPLETE LAA SEAL. LATER THAT DAY, THE SUBJECT BECAME HYPOTENSIVE AND THE RAPID RESPONSE TEAM WAS CALLED. THE SUBJECT WAS GIVEN 500 CC OF NORMAL SALINE BOLUS. ON EVALUATION, THE SUBJECT HAD SCATTERED ECCHYMOSIS ON THEIR ABDOMEN WITHOUT OBVIOUS OUTWARD BLEEDING AND RIGHT GROIN ACCESS SURROUNDING ECCHYMOSIS WITHOUT PALPABLE HEMATOMA. COMPUTED TOMOGRAPHY (CT) REVEALED EVIDENCE OF LARGE PELV

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension

  MAUDE report 10561551 ↗
• MalfunctionSep 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEMS (WDS) WERE USED. DURING THE DEPLOYMENT OF THE WDS, THE ANTERIOR CURVE SHEATH KINKED NEAR THE TRANS-SEPTAL AREA. THE PHYSICIAN WAS ABLE TO PERFORM A FULL RECAPTURE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WAS AND NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10544432 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS OCCURRED AND THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PATIENTS ACTIVATED CLOTTING TIME (ACT) WAS TESTED AS 108 BUT WAS CONSIDERED INCORRECT. AS THE ACT WAS BEING RETESTED, THE PIGTAIL WAS ADVANCED OVER A WIRE INTO THE WAS. UPON REMOVAL OF THE WIRE, A THROMBUS WAS VISUALIZED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PHYSICIAN PERFORMED ASPIRATION ON THE WAS AND ADDITIONAL HEPARIN WAS GIVEN UNTIL ACT WAS ACHIEVED OVER 300. THE SHEATH WAS REMOVED AND THE GROIN PUNCTURE WAS HELD BY A NON BOSTON SCIENTIFIC 16F SHEATH OVER THE WIRE. A NEW DOUBLE CURVE SHEATH WAS OPENED TO SUCCESSFULLY COMPLETE THE CASE. THE PATIENT PRESENTED NEUROLOGICAL DEFICITS UPON WAKING UP FROM THE PROCEDURE. AN IMMEDIATE CT SCAN OF THE HEAD CONFIRMED LEFT MIDDLE CEREBRAL ARTERY (MCA) STROKE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT AND A SUCCESSFUL LEFT MCA THROMBECTOMY WAS PERFORMED. THE PATIENT WAS CLEARED BY A NEUROLOGIST TO RESTART THEIR ANTICOAGULATION. THE PATIENT REMAINE

  Patient problems: Stroke/CVA; Thrombosis

  MAUDE report 10532911 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED. THE FIRST 24MM CLOSURE DEVICE WAS DEPLOYED TOO PROXIMAL AND A FULL RECAPTURE WAS PERFORMED WITH NO EFFUSION NOTED. THE PHYSICIAN CHANGED THE WAS AND A NEW 24MM DEVICE WAS PREPPED. THE PIGTAIL WAS REMOVED BUT THE DEVICE WAS UNABLE TO OBTAIN BLEED BACK. HOWEVER, THE WAS WAS MOVED PROXIMAL UNTIL BLOOD WAS ATTAINED WITH NO EFFUSION NOTED. DUE TO THE PROXIMAL LOCATION OF THE SHEATH, THE PIGTAIL WAS RE-INSERTED TO GET BACK IN POSITION. THE PHYSICIAN INJECTED CONTRAST THAT REVEALED THE PIGTAIL TO BE OUTSIDE THE BACK WALL OF THE LAA. NO EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PHYSICIAN PULLED EVERYTHING PROXIMAL AND A SMALL EFFUSION WAS NOTED. ADDITIONALLY, THE PATIENT BECAME HYPOTENSIVE. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 1000ML OF FLUID WAS REMOVED AND PROTAMINE WAS GIVEN. THE PATIENT WAS TAKEN TO CT SURGERY AND ATRIAL CLIP WAS PERFORMED. THE PATIENT WAS EXTUBATED AND DISCHARGED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10519185 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION, PERFORATION, AND CARDIAC ARREST OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED. PRIOR TO REMOVING THE PIGTAIL TO IMPLANT THE DEVICE, THE ANESTHESIOLOGISTS POINTED OUT A 2.5CM PERICARDIAL EFFUSION THAT WAS NOT PRESENT AT THE START OF THE PROCEDURE. THE PATIENT WAS IMMEDIATELY ADMINISTERED 50MG OF PROTAMINE AND A PERICARDIAL DRAIN WAS PLACED WITH 2200CC OF FLUIDS REMOVED. ADDITIONALLY, THE PATIENT WAS GIVEN 4 UNITS OF BLOOD AND WAS PLACED ON EPINEPHRINE DRIP. THE PATIENT WAS TRANSFERRED TO THE SURGICAL SUITE WHERE THE SURGEON NOTED A SMALL TEAR IN THE LOWER PULMONARY VEIN. THE SURGEON PROCEEDED TO STITCH THE TEAR AND CLIPPED THE APPENDAGE. THE PATIENT EXPERIENCED BRADYCARDIA POST SURGERY BUT REMAINED STABLE. THE NEXT DAY THE PATIENT CODED AND RECEIVED A PERMANENT PACEMAKER. THE PATIENT REMAINED HOSPITALIZED DUE TO A WOUND ON THEIR SHOULDER, OF UNKNOWN ORIGIN. THE PATIENT BECAME SEPTIC FROM THE WOUND AND DIED FOUR DAYS POST PROCEDURE.

  Patient problems: Cardiac Arrest; Cardiac Perforation; Pericardial Effusion

  MAUDE report 10437003 ↗
• InjuryApr 14, 2020Adverse 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 BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN PERFORMED THE TRANSSEPTAL PUNCTURE AND THE WAS INSERTED INTO THE PATIENT. AFTER THE WAS PLACED THROUGH THE SEPTUM, IT WAS NOTED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. THE PRESSURES WERE SLIGHTLY DECREASED BUT TREATED. THERE WAS NO INTERVENTION THAT WAS REQUIRED FOR THE PATIENT. THE PROCEDURE WAS CONTINUED AND A 33MM DEVICE WAS IMPLANTED SUCCESSFULLY IN THE LAA OF THE PATIENT. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED. THE PATIENT WAS DOING FINE POST PROCEDURE FOLLOWING THESE EVENTS.

  Patient problems: Pericardial Effusion

  MAUDE report 9960197 ↗
• InjuryMar 9, 2020Adverse 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 ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE WAS POSITIONED IN THE LAA AND THE FIRST 24MM CLOSURE DEVICE WAS DEPLOYED. THE DEVICE DID NOT MEET RELEASE CRITERIA, SO A FULL RECAPTURE WAS PERFORMED. THIS DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND CLOSURE DEVICE WAS INSERTED INTO THE WAS. THE PHYSICIAN FELT THE PATIENT COUGH AT THE TIME THE SECOND 24MM DEVICE DISTAL MARKER BAND WAS BEING MATCHED WITH THE WAS. BEFORE ATTEMPTING TO DEPLOY THE SECOND DEVICE A SLIGHT CONTRAST INJECTION WAS PERFORMED TO VISUALIZE EXACTLY WHERE THE END OF THE DEVICE WAS LOCATED IN RELATION TO THE BACK WALL OF THE LAA. THAT INJECTION SHOWED THAT THE CONTRAST WAS LEAVING THE LAA AND GOING INTO THE PERICARDIAL SPACE. THE PHYSICIAN CONTINUED THE PROCEDURE AND DEPLOYED THE SECOND DEVICE IN THE LAA, BUT IT ALSO DID NOT MEET RELEASE CRITERIA AND WAS FULLY RECAPTURED. TRANSESOPHAGEAL ECHOCARDIOGRAM IMAGING SHOWED THAT FLUID WAS ACCUMULATING IN THE PERICARDIAL SPACE. THE PHYSICIAN GAVE THE PATIE

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 9808302 ↗
• InjuryFeb 5, 2020Adverse 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 BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN POSITIONED THE WAS INTO THE APPENDAGE AND ADVANCED THE WDS INTO THE SHEATH ALL THE WAY UP TO THE DISTAL END. RIGHT BEFORE THE CLOSURE DEVICE WAS READY TO DEPLOY, THE PHYSICIAN SHOT A LITTLE BIT OF CONTRAST JUST TO CONFIRM POSITION AND NOTED THAT THERE WAS A PERICARDIAL EFFUSION. THE PROCEDURE WAS CONTINUED WITH NO TREATMENT FOR THE PERICARDIAL EFFUSION. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THE PHYSICIAN MONITORED THE EFFUSION, WHICH DID NOT GET ANY WORSE AND ACTUALLY SUBSIDED. PROTAMINE REVERSAL WAS GIVEN, BUT NO FURTHER INTERVENTION WAS NEEDED. THE PHYSICIAN DID NOT HAVE TO DO ANYTHING, THEY JUST MONITORED IT AND IT DID NOT WORSEN. PROTAMINE REVERSAL WAS THE ONLY STEP THEY TOOK TOWARDS CORRECTING IT. THE PATIENT REMAINED STABLE AND WAS DOING FINE.

  Patient problems: Pericardial Effusion

  MAUDE report 9673873 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS WAS PRESENT IN THE PATIENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO USED. AFTER THE PHYSICIAN PERFORMED THE TRANSSEPTAL PUNCTURE, THE SHEATH WAS INSERTED AND OUT ACROSS THE SEPTUM. AT THIS TIME A THROMBUS WAS VISUALIZED IN THE PATIENT ON THE WIRE THAT WAS THROUGH THE WAS. THE PHYSICIAN GAVE HEPARIN TO THE PATIENT TO RESOLVE THE THROMBUS AND THE PROCEDURE WAS ENDED. NO OTHER COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE FOLLOWING THESE EVENTS.

  Patient problems: Thrombosis

  MAUDE report 9673832 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS OCCURRED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. UPON ADVANCING THE WAS AND PIGTAIL CATHETER, A THROMBUS WAS NOTED TO BE WRAPPED AROUND THE TIP OF THE PIGTAIL. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE CLOT, BUT WAS UNSUCCESSFUL. AT THIS TIME, THE PIGTAIL WAS PULLED IN THE WAS AND THE CLOT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE CONTINUED AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT FURTHER COMPLICATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. PATIENT IS STABLE AND HAS BEEN DISCHARGED.

  Patient problems: Thrombosis

  MAUDE report 9553495 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A HEMATOMA. 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. THE PROCEDURE WAS COMPLETED AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. AFTER THE PROCEDURE WAS COMPLETED THE PATIENT HAD A DROP IN THEIR BLOOD PRESSURE AND A LARGE HEMATOMA WAS NOTED IN THE RIGHT GROIN AREA. THE PATIENT WAS STABLE FOLLOWING THESE EVENTS AND WAS SENT TO THE INTENSIVE CARE UNIT FOR OBSERVATION. NO INTERVENTION WAS REQUIRED FOR THE EVENTS AND THE PATIENT RECOVERED AND IS DOING WELL. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 9324194 ↗
• InjuryNov 6, 2019Adverse 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. SOME CONFUSION OCCURRED AND THE HEPARIN WAS NOT ADMINISTERED AT THE CORRECT TIME. IT WAS ADMINISTERED FOUR MINUTES AFTER THE WATCHMAN ACCESS SYSTEM CROSSED THE SEPTUM. AS THE 21MM WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM WAS ADVANCED INTO THE ACCESS SYSTEM, A CLOT WAS NOTICED COMING OUT OF THE PROXIMAL PORTION OF THE ACCESS SYSTEM. THE CLOSURE DEVICE WAS NEVER DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED AND THE PHYSICIAN ASPIRATED THE CLOT FROM THE ACCESS SYSTEM WITH A 60CC SYRINGE. THE CLOT WAS ASPIRATED SUCCESSFULLY. THE ACCESS SYSTEM WAS REMOVED FROM THE BODY. ANESTHESIA AND THE PHYSICIAN PERFORMED A NEUROLOGICAL ASSESSMENT ON THE PATIENT AFTER SHE WAS AWAKE AND SHE WAS NOTED TO BE FINE.

  Patient problems: Thrombosis; Thrombosis/Thrombus

  MAUDE report 9288768 ↗
• InjuryOct 25, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR SEEN IN THE DEVICE AND THE PATIENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED. A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS ADVANCED. THE CLOSURE DEVICE WAS DEPLOYED IN THE LAA, BUT WAS TOO PROXIMAL AND NEEDED TO BE FULLY RECAPTURED. A NEW WDS WAS OPENED AND INSERTED INTO THE WAS. AS THE DEVICE WAS BEING ADVANCED AIR WAS VISUALLY SEEN INSIDE THE WAS. THE PHYSICIAN WAS ABLE TO ASPIRATE THE AIR AND PULLED THE DEVICE BACK OUT. THEY RE-FLUSHED PRIOR TO INTRODUCING AGAIN. IT WAS NOTED THAT THERE MAY HAVE BEEN A TRACE AMOUNT OF AIR IN THE APPENDAGE AND THEY WERE ABLE TO ASPIRATE IT THROUGH THE WAS. THE PATIENT HAD NO ADVERSE EVENT. THE PROCEDURE WAS CONTINUED AND THEY WERE ABLE TO DEPLOY THE CLOSURE DEVICE IN THE LAA SUCCESSFULLY. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED. THE PATIENT WAS REPORTED TO BE FINE AND STABLE.

  Patient problems: Air Embolism

  MAUDE report 9241862 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS THROMBUS IN THE SHEATH. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN HAD REMOVED THE DILATOR AND WAS FLUSHING THE WAS WHEN THEY DISCOVERED THAT THERE WAS A THROMBUS. THE PHYSICIAN COULD NOT ASPIRATE IT OUT AND DECIDED TO PULL THE ENTIRE SHEATH OUT OF THE PATIENT. IT WAS NOTED THAT THE THROMBUS WAS INSIDE OF THE WAS. THERE WERE NO PATIENT COMPLICATIONS THAT RESULTED FROM THIS EVENT. THE PATIENT WAS FINE. A NEW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Thrombosis

  MAUDE report 9209156 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. TRANSSEPTAL PUNCTURE WAS PERFORMED. ONCE THE WATCHMAN ACCESS SYSTEM (WAS) CROSSED THE SEPTUM THE PATIENT BEGAN TO DECOMPENSATE AND THEIR BLOOD PRESSURE DROPPED. THE PATIENT WENT INTO RIGHT SIDE HEART FAILURE AND THE PHYSICIANS DECIDED TO TERMINATE THE CASE. ANESTHESIA TOOK OVER AND PROVIDED MEDICAL MANAGEMENT. IN ADDITION THEY PLACED A SWAN-GANZ CATHETER TO MEASURE THE RIGHT HEART PRESSURES. NO OTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AT BASELINE.

  Patient problems: Heart Failure; Low Blood Pressure/ Hypotension

  MAUDE report 9204352 ↗
• InjuryOct 17, 2019Adverse 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 BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS BEING INSERTED INTO THE PATIENT AND THE PHYSICIAN FELT THE TRAJECTORY FOR POSITIONING IN THE LAA WAS NOT IDEAL. THE PHYSICIAN HAD TO TURN THE SHEATH COUNTERCLOCKWISE MORE THAN USUAL. THE WAS TOOK A 360 TURN AND IT WENT THROUGH THE WALL OF THE APPENDAGE. THE PROCEDURE WAS IMMEDIATELY STOPPED. THE PATIENT HAD A PERICARDIAL EFFUSION THAT HAD DEVELOPED FROM THIS AND THEIR BLOOD PRESSURE STARTED TO DECREASE. THE PATIENT WAS TAPPED ON THE TABLE AND THE PHYSICIAN REMOVED 1200CC OF FLUID. THE EFFUSION DID NOT RESOLVE AND THEIR WAS A HOLE IN THE APPENDAGE SO THE SURGEON WAS CALLED IN. THE CARDIAC SURGEON PERFORMED A PERICARDIAL WINDOW AND CLIPPED OFF THE APPENDAGE OF THE PATIENT. THE PATIENT RECOVERED AND IS STABLE FOLLOWING THESE EVENTS AND THEY WERE BROUGHT TO THE INTENSIVE CARE UNIT FOR FURTHER MONITORING. THE PATIENT IS CURRENTLY DOING WELL FOLLOWING THESE EVENTS.

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

  MAUDE report 9203409 ↗
• DeathSep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION WITH SUBSEQUENT TAMPONADE AND PATIENT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED DEEP IN THE LAA. A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS ADVANCED VIA THE WAS. PRIOR TO SNAPPING THE DEVICES INTO PLACE, A PERFORATION WITH SUBSEQUENT PERICARDIAL EFFUSION WAS NOTED VIA FLUOROSCOPY, LIKELY CAUSED BY THE WAS. THE EFFUSION WAS CONFIRMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PROCEDURE CONTINUED AND THE CLOSURE DEVICE WAS DEPLOYED WHILE A PERICARDIOCENTESIS KIT WAS BEING PREPARED. THE PATIENT EXPERIENCED CARDIAC TAMPONADE. THE RELEASE CRITERIA WAS ASSESSED WHILE THE PATIENT'S CHEST WAS PREPPED. THE CRITERIA WAS MET AND THE DEVICE WAS RELEASED FROM THE CORE WIRE. THE PHYSICIAN GAVE ANTICOAGULATION REVERSAL AND PERFORMED A PERICARDIAL TAP. THE PHYSICIAN WAS UNABLE TO SLOW THE BLEEDING OR STABILIZE THE PATIENT. SURGICAL INTERVENTION WAS REQUESTED. THE PATIENT WAS ADMINISTERED BLOOD AND THE SURGEON PERFORMED A CUT DOWN TO THE STERNUM. THE BLEEDING COULD NOT BE CONTROLLED AND THE PATIENT PASSED AWAY.

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

  MAUDE report 8961954 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS OCCURRED. A WATCHMAN ACCESS SYSTEM (WAS) ANTERIOR CURVE AND WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. AFTER THE TRANS-SEPTAL PUNCTURE WAS PERFORMED AND THE WAS IN THE PATIENT, A THROMBUS WAS NOTED IN THE RIGHT ATRIUM AND MORE HEPARIN WAS ADMINISTERED. A TOTAL OF 23,000 UNITS OF HEPARIN WAS GIVEN DURING THE PROCEDURE WITH AN ACTIVATED CLOTTING TIME (ACT) OF 230. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT REMAINED STABLE WITHOUT SIGNS OF STROKE. THROMBUS WAS STILL SEEN AT THE END OF THE PROCEDURE. PATIENT WAS DISCHARGED AND WILL FOLLOW RECOMMENDED ANTI-COAGULATION POST IMPLANT THERAPY PER PHYSICIAN.

  Patient problems: Thrombosis

  MAUDE report 8941299 ↗
• MalfunctionJun 17, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 22 MAY 2019. IT WAS REPORTED THAT A KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27 MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. DURING THE PROCEDURE, A KINK WAS NOTED IN THE WAS AS THE PHYSICIAN WAS INSERTING THE CLOSURE DEVICE INTO THE SHEATH. THE DEVICE THEN TELESCOPED THROUGH THE DELIVERY SYSTEM AND THE OUTSIDE HOUSING ON THE DEVICE CRIMPED AS WELL. BOTH THE SHEATH AND THE DELIVERY SYSTEM WERE REMOVED FROM THE BODY. ANOTHER WAS INSERTED AND THE CASE CONTINUED AND WAS COMPLETED WITHOUT COMPLICATION. THERE WERE NO REPORTED COMPLICATIONS WITH THE PATIENT. HOWEVER, THE DEVICE ANALYSIS REVEALED INNER LINER DELAMINATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705663 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130013. One submission often covers many models, so check the product and lot details in each record.

• Z-2766-2015 · Aug 25, 2015 · Terminated
  Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635
• Z-2765-2015 · Aug 25, 2015 · Terminated
  Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060,