WATCHMAN® Access System M635TU10060Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 08714729838197), received between Nov 17, 2016 and Jul 21, 2020 — classified as 2 deaths, 50 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AIR EMBOLISM OCCURRED. 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 USED. THE WAS WAS POSITIONED IN THE LAA OF THE PATIENT WHEN THE PHYSICIAN NOTED THAT THERE WAS AIR IN THE APPENDAGE. THE PROCEDURE WAS COMPLETED AND THE PATIENT RECEIVED A 27MM CLOSURE DEVICE. THERE WERE NO INTERVENTIONS PERFORMED. THE PATIENT HAD NO HEMODYNAMIC CHANGES AND HAD NO RESIDUAL EFFECTS AS A RESULT OF THIS EVENT. THE PATIENT WAS DISCHARGED DOING FINE THE FOLLOWING DAY.

  Patient problems: Air Embolism

  MAUDE report 10303419 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN AIR EMBOLISM. 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 WAS WAS POSITIONED IN THE LAA WHEN THE PHYSICIAN NOTED THAT THERE WAS AN AIR EMBOLISM IN THE CORONARIES OF THE PATIENT. THE PATIENT WAS OXYGENATED AT 100% AND THERE WAS A SMALL DROP IN BLOOD PRESSURE. THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE BEING IMPLANTED IN THE PATIENT. THERE WERE NO OTHER COMPLICATIONS THAT OCCURRED. THE PATIENT HAD NO RESIDUAL EFFECTS DUE TO THE AIR AND THEY WERE FINE.

  Patient problems: Air Embolism

  MAUDE report 9753143 ↗
• InjuryFeb 3, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR IN THE DEVICE. 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 WAS POSITIONED IN THE LAA OF THE PATIENT AND THE WDS WAS INSERTED INTO THE ACCESS SHEATH. WHEN THE DEVICE WAS INSERTED, AIR ENTERED INTO THE WAS. THE AIR WAS VISUALIZED ON TRANSESOPHAGEAL ECHOCARDIOGRAM AND MONITORED UNTIL IT RESOLVED. DURING THIS TIME THE PATIENT HAD A TRANSIENT ST SEGMENT ELEVATION AND BECAME HYPOTENSIVE. THESE WERE MEDICALLY MANAGED AND THE PATIENT RETURNED TO NORMAL WITHIN 10MINUTES. AFTER THE PATIENT STABILIZED, THE PROCEDURE WAS CONTINUED. THE CLOSURE DEVICE WAS DEPLOYED AND SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT DEFICITS OR ISSUES THAT OCCURRED POST PROCEDURE. THE PATIENT WAS DOING FINE.

  Patient problems: Low Blood Pressure/ Hypotension; ST Segment Elevation

  MAUDE report 9661356 ↗
• MalfunctionJan 3, 2020Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE DAMAGE 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. WHILE THE WDS WAS PLACED INTO THE WAS, A KINK TO THE SHEATH WAS NOTED. THE PHYSICIAN WAS ABLE TO MANAGE THE SHEATH IN SUCH A WAY TO OBTAIN MINIMAL RESISTANCE AND PROCEED WITH DEPLOYMENT. AFTER THE DEVICE WAS SUCCESSFULLY DEPLOYED, A 1CM STRAND OF WHAT APPEARED TO BE A POTENTIAL THROMBUS OR FIBROUS TISSUE WAS NOTED ON THE TIP OF THE WAS. AT THIS TIME, THE PHYSICIAN ASPIRATED THE SHEATH IN ATTEMPT TO RESOLVE THE OBJECT, BUT NO CHANGE OCCURRED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE DEVICE WAS RELEASED AND IMPLANTED. THE SHEATH WAS THEN PULLED OUT OF THE PATIENT AT WHICH POINT THE PHYSICIAN NOTED A THIN WIRE PROTRUDING FROM THE TIP OF THE SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE, BUT WAS NOT ABLE TO SEPARATE IT FROM THE SHEATH. NO FURTHER DAMAGE WAS NOTED TO THE SHEATH. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547193 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PROCEDURAL COMPLICATIONS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. WHILE GAINING ACCESS AT THE GROIN, DIFFICULTY WAS NOTED DURING USE OF THE TRANSSEPTAL SHEATH AND A VASCULAR ACCESS SHEATH WAS USED TO RESOLVE THE ISSUE. ONCE ACCESS WAS GAINED, A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS ADVANCED. THE WAS COULD NOT BE POSITIONED PROPERLY IN THE LAA AND WAS THEREFORE EXCHANGED FOR A SINGLE CURVE WAS. AT THIS TIME THE PHYSICIAN NOTED THAT THERE WERE SOME EKG CHANGES THAT INDICATED LEFT BUNDLE BRANCH BLOCK AND SOME FLUCTUATIONS IN THE PATIENTS BLOOD PRESSURE. THE PHYSICIAN IMAGED THE FEMORAL VEIN WHICH REVEALED SOME SEEPAGE AROUND AN AREA WHERE THERE WAS SOME TORTUOSITY. THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE AT THE END OF THE CASE. THERE WAS NO EVIDENCE OF EFFUSION. A VASCULAR SURGEON WAS CONSULTED HOWEVER IT WAS DETERMINED NO INTERVENTION WAS NECESSARY. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 9433648 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CARDIAC PERFORATION AND SUBSEQUENT PERICARDIAL EFFUSION OCCURRED. VENOUS ACCESS WAS OBTAINED AND TRANSEPTAL ACCESS WAS GAINED. A WATCHMAN ACCESS SYSTEM (WAS) SINGLE CURVE WAS POSITIONED AND WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. UPON REMOVAL OF THE DILATOR FROM THE SHEATH, THE WAS FLIPPED DOWN AND CAUSED A SMALL PERFORATION TO THE AORTA, CREATING A PERICARDIAL EFFUSION. CASE WAS ABORTED. PATIENT WAS SENT TO SURGERY FOR PERFORATION REPAIR. PATIENT IS STABLE AND HAS BEEN DISCHARGED.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 9268662 ↗
• InjuryAug 26, 2019Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED AIR EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED IN THE LAA AND IMMEDIATELY AIR WAS NOTICED WITHIN THE WAS. THE AIR ENTERED THE PATIENT, BUT WAS ABLE TO BE ASPIRATED FROM THE LAA. THE WAS WAS REMOVED AND THEY EXCHANGED FOR ANOTHER WAS TO COMPLETE THE PROCEDURE SUCCESSFULLY. ONCE IT WAS REMOVED FROM THE PATIENT, THEY NOTICED THE HEMOSTASIS VALVE ON THE WAS HAD A LEAK WHICH INTRODUCED THE AIR. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT HAD NO NEUROLOGICAL DEFICITS AND IS FINE.

  Patient problems: Air Embolism

  MAUDE report 8932784 ↗
• MalfunctionJul 2, 2019Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS RESISTANCE FELT AND DAMAGE TO THE ACCESS SYSTEM. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE WAS WAS POSITIONED IN THE LAA AND THE CLOSURE DEVICE WAS INSERTED INTO THE WAS. UPON DEPLOYMENT OF THE DEVICE, THE PHYSICIAN NOTED ADDITIONAL RESISTANCE WAS FELT. THE DEVICE WAS STILL ABLE TO BE SUCCESSFULLY DEPLOYED AND IMPLANTED IN THE LAA OF THE PATIENT. UPON REMOVAL OF THE WAS FROM THE BODY, THE PHYSICIAN NOTICED THAT AT THE DISTAL END THERE WAS AN EXPOSED THREAD OR FILAMENT OR A PIECE OF THE INNER LINING OF THE SHEATH THAT WAS EXPOSED. THEY BELIEVED THAT THIS WAS CAUSING THE RESISTANCE AND COMPLICATING THE PROCEDURE. ULTIMATELY, THE PROCEDURE WAS SUCCESSFUL AND NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753174 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERFORATION AND A PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE ANATOMY WAS NOTED TO BE DIFFICULT AND CHICKEN WING IN SHAPE. THEY ATTEMPTED BOTH AN ANTERIOR CURVE AND THEN A SINGLE CURVE WATCHMAN ACCESS SYSTEM (WAS) FOR ADEQUATE POSITIONING. A 27MM WATCHMAN LAA CLOSURE DEVICE WAS DEPLOYED BUT DID NOT MEET RELEASE CRITERIA. THE DEVICE WAS RECAPTURED. THEY DECIDED TO RE-CROSS THE SEPTUM IN A DIFFERENT POSITION. THE PHYSICIAN FELT THAT THERE WAS A LITTLE EXTRA RESISTANCE WITH THE TRANSSEPTAL SHEATH WHEN THE RE-CROSS WAS PERFORMED. AFTER THIS WAS PERFORMED A PERFORATION OCCURRED. THE PHYSICIAN SAW A SMALL PERICARDIAL EFFUSION BOTH ON INTER-CARDIAC ECHO AND TRANSESOPHAGEAL ECHO. ULTIMATELY THE PATIENT WAS MONITORED. THEIR BLOOD PRESSURE DID DROP A LITTLE BIT BUT THERE WAS NEVER A TAMPONADE THAT OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED WHICH REMOVED 200CC OF BLOOD. AFTER THAT, THERE WAS NO MORE ATTEMPT TO IMPLANT THE DEVICE BECAUSE PROTAMINE HAD BEEN GIVEN. THE PHYSICIAN DID NOT WANT TO HEPARINIZE ANY LONGER. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABLE FOLLOWING THESE EVENTS.

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

  MAUDE report 8577159 ↗
• InjuryMar 13, 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) SINGLE CURVE AND 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. BEFORE THE START OF THE PROCEDURE, A BASELINE PERICARDIAL EFFUSION WAS NOTED. PRIOR TO CROSSING THE SEPTUM, A THROMBUS WAS VISUALIZED IN THE RIGHT ATRIUM. NO INTERVENTIONS WERE PERFORMED FOR THE THROMBUS; HOWEVER, THE PHYSICIAN GAVE HEPARIN AFTER THE SEPTUM WAS CROSSED. THE PROCEDURE CONTINUED AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. APPROXIMATELY, TWO HOURS POST-PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED CHEST PAIN. A CARDIAC TAMPONADE WAS DISCOVERED AND A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 500 CC OF FLUID FROM THE PERICARDIAL SPACE. THE DRAIN WAS REMOVED AND THE PATIENT WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 8418176 ↗
• InjuryDec 19, 2018Adverse 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) SINGLE CURVE WAS POSITIONED AND A 24 MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE WAS WAS POSITIONED AND PRIOR TO INTRODUCING THE WDS, THE PHYSICIAN DECIDED TO EXCHANGE THE SINGLE CURVE WAS FOR A DOUBLE CURVE. AT THIS TIME, THE PHYSICIAN REMOVED THE DEVICE FROM THE LAA AND INTRODUCED THE PIGTAIL CATHETER. PRIOR TO INSERTING THE NEW WAS, A LARGE THROMBUS WAS NOTED JUST DISTAL TO THE OSTIUM OF THE LAA. IMMEDIATELY, THE SINGLE CURVE WAS WAS REMOVED FROM THE PATIENT AND THE CASE WAS ABORTED. NEITHER THE DOUBLE CURVE WAS NOR THE WDS WERE INTRODUCED TO THE PATIENT. PATIENT DID NOT SUSTAIN ANY NEUROLOGICAL OR CARDIOVASCULAR DEFICITS.

  Patient problems: Thrombosis

  MAUDE report 8179525 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERFORATION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS USED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED TO BE USED. IT WAS REPORTED THAT THE WAS WAS INTRODUCED INTO THE BODY AND PLACED IN THE LAA USING A PIGTAIL. ONCE THE PHYSICIAN WAS AT THE DEPTH THAT WAS REQUIRED FOR THE DEVICE, THE PHYSICIAN REMOVED THE PIGTAIL. WHEN THIS WAS DONE THE SHEATH JUMPED FORWARD AND PERFORATED THE LEFT ATRIAL APPENDAGE. THE PHYSICIAN CALLED THE SURGEON IN TO EVALUATE. AT THIS TIME, THERE WAS NO EFFUSION NOTED. THE SURGEON FELT IT WAS BEST TO CLIP THE LAA AND SURGICALLY REPAIR THE PERFORATION. THE PATIENT WAS PREPPED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS STABLE AND RECOVERING WELL. THE WATCHMAN PROCEDURE WAS NOT FINISHED, NO IMPLANTATION OF THE DEVICE OCCURRED.

  Patient problems: Cardiac Perforation

  MAUDE report 8172337 ↗
• InjuryNov 19, 2018Adverse 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. WHEN THE WAS WAS INSERTED INTO THE BODY THERE WAS A BLOOD CLOT IN THE TIP OF THE SHEATH. THE PHYSICIAN REMOVED THE DEVICE, FLUSHED THE DEVICE AND CHECKED TO ENSURE THE ACTIVATED CLOTTING TIME (ACT) WAS WITHIN ADEQUATE RANGE. THE ACT WAS WITHIN AN ADEQUATE RANGE AS IT WAS BETWEEN 275-358. AFTER PERFORMING ALL THIS THE WAS REINSERTED INTO THE PATIENT. ONCE AGAIN THE BLOOD CLOTTED AROUND THE SHEATH. THE PHYSICIAN REMOVED THE DEVICE AND REPLACED IT WITH A NEW WAS. THE SECOND WAS HAD NO ISSUES AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. THE PATIENT IS DOING FINE.

  Patient problems: Thrombosis

  MAUDE report 8083920 ↗
• MalfunctionOct 31, 2018Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DEFECT IN THE ACCESS SHEATH: 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 CLOSURE DEVICE WAS BEING PLACED IN THE LAA, BUT IT WAS NOT SEATED PROPERLY SO THE PHYSICIANS CHOSE TO RECAPTURE THE DEVICE. AS THE DEVICE WAS BEING RECAPTURED A DEFECT WAS NOTED IN THE TIP OF THE SHEATH. THE WAS REMOVED AND EXCHANGED FOR A NEW WAS. WHEN THE ACCESS SHEATH WAS LOOKED AT IT WAS NOTED THAT THE SOFT TIP HAD FRAYED APART. THERE WERE NO PATIENT COMPLICATIONS AND A NEW 33MM WDS AND A NEW WAS WERE USED TO SUCCESSFULLY IMPLANT AND RELEASE THE CLOSURE DEVICE IN THE LAA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024272 ↗
• InjuryOct 18, 2018Adverse 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) AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE WAS COMPLETED IT WAS NOTICED THAT THERE WAS AN EFFUSION. THE PHYSICIANS ATTEMPTED A PERICARDIOCENTESIS TO DRAIN THE BLOOD, BUT THEY WERE UNSUCCESSFUL. THE PATIENT THEN WENT TO THE OPERATING ROOM WHERE THEY PERFORMED A PERICARDIAL WINDOW, BUT STILL COULD NOT STOP THE BLEEDING. THE PHYSICIANS THEN DID A STERNOTOMY AND THEY WERE SUCCESSFUL IN THE STOPPING THE BLEEDING. THE PATIENT MADE A FULL RECOVERY AND WAS DISCHARGED HOME.

  Patient problems: Pericardial Effusion

  MAUDE report 7979445 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION AND A PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. DURING THE PROCEDURE THE PHYSICIAN MADE A FORWARD MOVEMENT WHEN THE CLOSURE DEVICE WAS IN THE LAA. THE FEET OF THE DEVICE WENT INTO THE PATIENT'S HEART AND WAS PERFORATED. THIS PERFORATION LEAD TO THE PERICARDIAL EFFUSION. THE PATIENT WAS BROUGHT TO SURGERY TO REMOVE THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE LAA WAS REMOVED. THE PATIENT IS CURRENTLY DOING VERY WELL FOLLOWING THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 7834003 ↗
• InjuryAug 23, 2018Adverse 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 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS SUCCESSFUL AND THE 21MM CLOSURE DEVICE WAS RELEASED AND IMPLANTED INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. AFTER THE PROCEDURE WAS COMPLETED IT WAS REPORTED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A PERICARDIAL TAP AND REMOVED 250ML OF FLUID. THE PATIENT IS STABLE AND DOING FINE.

  Patient problems: Pericardial Effusion

  MAUDE report 7808965 ↗
• MalfunctionAug 23, 2018Material 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 USED TO DEPLOY A WATCHMAN® CLOSURE DEVICE. DURING THE DEVICE RECAPTURE THE WAS BECAME KINKED. THE (WAS) WAS EXCHANGED FOR A NEW ONE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808432 ↗
• InjuryAug 22, 2018Adverse 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 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS DEPLOYED AND IN DOING SO THE FEET OF THE DEVICE CREATED A PERFORATION IN THE APPENDAGE. IT WAS NOTICED AFTER THE PERFORATION OCCURRED THAT THERE WAS PERICARDIAL EFFUSION. THE PATIENT RECEIVED 50CC OF PROTAMINE, BUT THE EFFUSION CONTINUED. THE PHYSICIAN THEN DECIDED TO START A PERICARDIAL TAP AND TOOK OFF AROUND A THOUSAND UNITS OF BLOOD WHICH WAS REPLACED. DURING THIS ENTIRE EVENT THE PATIENT WAS HEMODYNAMICALLY STABLE. AFTER TWO HOURS OF PERFORMING A PERICARDIAL TAP IT WAS DECIDED TO BRING THE PATIENT TO SURGERY. THE PATIENT WAS TREATED WITH AN ATRIAL CLIP WHILE IN SURGERY. THE PATIENT IS STABLE AND IS CONTINUING TO RECOVER.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 7806250 ↗
• InjuryJul 25, 2018Adverse 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 WAS ADMINISTERED AFTER THE TRANSEPTAL PUNCTURE AND THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS 319 SECOND. A 27 MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS INSERTED INTO THE WATCHMAN ® ACCESS SYSTEM. THE CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE SEAL. HOWEVER, AFTER THE CLOSURE DEVICE WAS IMPLANTED THERE WAS A CLOT ON THE SEPTUM LOCATED ON THE SIDE OF THE RIGHT ATRIUM. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Thrombosis

  MAUDE report 7717648 ↗
• InjuryJul 25, 2018Adverse 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 TRANSEPTAL PUNCTURE WAS PERFORMED AND AN UNSPECIFIED GUIDE WIRE WAS PLACED IN THE LEFT ATRIUM AND UPPER PULMONARY VEIN. THEN A WATCHMAN ® ACCESS SYSTEM WAS ADVANCED, BUT NEVER ENTERED THE LAA. AT THIS TIME THE PATIENT¿S BLOOD PRESSURE STARTED TO DROP, WHICH MAY HAVE BEEN CAUSED BY A PERFORATION WHICH LET TO A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS MONITORED FOR A COUPLE OF HOURS ON THE TABLE AND WAS THEN SENT TO HOLDING. WHILE IN HOLDING, THE PATIENT DECOMPENSATED FURTHER; THEIR BLOOD PRESSURE DROPPED. AN ATTEMPT WAS MADE TO WITHDRAW FLUID FROM THE PERICARDIUM, BUT THERE WAS CLOT INSIDE OF THE PERICARDIAL DRAIN SHEATH. A PERICARDIAL WINDOW WAS CUT TO RELIEVE THE PRESSURE. THE PATIENT IS CURRENTLY DOING WELL AND STABLE. THERE WAS NO WATCHMAN DEVICE IMPLANTED

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

  MAUDE report 7717622 ↗
• InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MFR: 2134265-2018-05516. IT WAS REPORTED THAT A AND A PERFORATION WITH SUBSEQUENT PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE WATCHMAN® ACCESS SYSTEM (WAS) WAS DEEP SEATED IN THE LAA. A 24 MM WATCHMAN ® LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS THEN ADVANCED. AFTER THE CLOSURE DEVICE WAS DEPLOYED, THE CLOSURE DEVICE WAS PARTIALLY RECAPTURED DUE TO A GAP THAT NEEDED TO BE REPOSITIONED. THEN AN ECHOCARDIOGRAM REVEALED A PUNCTURE WHICH LED TO A PERICARDIAL EFFUSION. THE PATIENT DID NOT EXPERIENCE CARDIAC TAMPONADE, OR CHANGES IN THEIR STATUS. THE CLOSURE DEVICE WAS FULLY RECAPTURED AND ANOTHER 24 MM WDS WAS INSERTED AND DEPLOYED TO SLOW THE PE DOWN. A PERICARDIOCENTESIS WAS THEN PERFORMED. THEY LEFT THE 2ND 24 MM CLOSURE DEVICE IN PLACE; HOWEVER, THE PATIENT WENT TO SURGERY TO SUTURE A HOLE AT THE TIP OF THE APPENDAGE. THE PATIENT WAS EXTUBATED, TALKING, AND WAS DOING FINE. THEY WILL BE DISCHARGED ONCE A PACER PROCEDURE HAS BEEN PERFORMED.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 7583721 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2018-05152. 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 AT THE DEEPEST PART OF THE LAA THAT COULD BE SAFELY REACHED AND A 21MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS ADVANCED. THE CLOSURE DEVICE WAS DEPLOYED IN THE LAA AND SHORTLY AFTER DEPLOYMENT, THE ECHOCARDIOGRAPHER NOTICED A GROWING PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO EXTRACT FLUID FROM THE PERICARDIUM. THE PATIENT WAS STABILIZED AND THE CLOSURE DEVICE WAS IMPLANTED AND RELEASED FROM THE CORE WIRE.

  Patient problems: Pericardial Effusion

  MAUDE report 7577233 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2018-05110. IT WAS REPORTED A PERICARDIAL EFFUSION AND TAMPONADE OCCURRED. ON (B)(6) 2018, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN® ACCESS SYSTEM AND 33MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WERE USED. THE CLOSURE DEVICE WAS DEPLOYED, BUT DID NOT MEET THE RELEASE CRITERIA. THEREFORE, IT WAS FULLY RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS EXCHANGED FOR A 30MM WATCHMAN ® LAA CLOSURE DEVICE, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO EFFUSION NOTED ON THE ECHOCARDIOGRAM. ABOUT TWO HOURS POST PROCEDURE, A CODE BLUE WAS CALLED ON THE PATIENT BECAUSE THEY WENT INTO CARDIAC ARREST. THERE WAS NO EKG STRIP DOCUMENTING NO RHYTHM. CHEST COMPRESSIONS WERE PERFORMED AND THE CODE BLUE WAS CANCELLED. AN ECHOCARDIOGRAM WAS PERFORMED POST CHEST COMPRESSIONS WHICH NOTED A PERICARDIAL EFFUSION AND TAMPONADE. ABOUT 800ML OF FLUID WAS TAPPED FROM THE PERICARDIUM. THE PATIENT WAS DOING BETTER THE NEXT COUPLE OF DAYS, BUT HAD A PLEURAL EFFUSION WHERE ONE LITER OF FLUID WAS TAPPED OUT. AS DAYS WENT ON, THE PATIENT DEVELOPED A HEMOTHORAX AND THREE LITERS OF FLUID WAS TAPPED OUT. ON (B)(6), THE PATIENT DEVELOPED BRADYCARDIA

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 7575064 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2018-05388. IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. IMAGING ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS VERY HAZY AND TRANSSEPTAL CROSSING WAS NOTED TO BE VERY DIFFICULT. A WATCHMAN® ACCESS SYSTEM (WAS) WAS USED WITH A 21 MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS). THE CLOSURE DEVICE WAS DEPLOYED AND RELEASED WITHOUT ISSUE. ABOUT 4 HOURS POST PROCEDURE, THE PATIENT STARTED EXPERIENCING SYMPTOMS OF NAUSEA AND BECAME HYPOTENSIVE. THEY TRIED TREATING THE SYMPTOMS WITH MEDICATION. THE PHYSICIAN THEN PERFORMED A TRANSTHORACIC ECHOCARDIOGRAM AND NOTICED THAT THERE WAS A SMALL PERICARDIAL EFFUSION. THE PATIENT RETURNED TO THE LAB AND PERICARDIOCENTESIS WAS PERFORMED; APPROXIMATELY 200-250 CC OF FLUID WAS EXTRACTED. AFTER THIS, THE PATIENT'S SYMPTOMS BEGAN TO IMPROVE AND THE PATIENT WAS DISCHARGED WITHOUT HARM. IT WAS NOTED THAT THE IMPLANTING PHYSICIAN BELIEVED THE SYMPTOMS POST PROCEDURE COULD HAVE ALSO BEEN RELATED TO THE PATIENT¿S GASTROINTESTINAL BLEEDING ISSUES IN CONJUNCTION WITH THE HEPARIN GIVEN DURING THE CASE.

  Patient problems: Low Blood Pressure/ Hypotension; Nausea; Pericardial Effusion

  MAUDE report 7574186 ↗

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,