WATCHMAN FXD Curve™ Access System M635TU80010Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00191506013806), received between Jul 5, 2022 and Apr 16, 2026 — classified as 1 death, 25 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 29, 2025Class IOpen, Classified

   Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

   Z-2434-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR WITH THE ACCESS SYSTEM. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED IN THE LAA OF THE PATIENT BUT DID NOT MEET RELEASE CRITERIA. THE WDS WAS REMOVED FROM THE PATIENT AND A NEW WDS WAS SELECTED TO BE USED. AS THE PHYSICIAN BEGAN TO INSERT THE NEW WDS INTO THE WAS, AIR WAS NOTED IN THE SIDE PORT OF THE WAS. THE PHYSICIAN FLUSHED AND ASPIRATED THE WAS BEFORE CONTINUING THE PROCEDURE. THE AIR WAS RESOLVED AND THE PROCEDURE WAS CONTINUED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED, AND THE PATIENT MADE A FULL RECOVERY FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900740 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AIR WAS OBSERVED AND THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, AND A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) WAS SELECTED TO BE USED. DURING THE PROCEDURE THE PHYSICIAN PERFORMED A FEMORAL VEIN PUNCTURE AND 5CC OF HEPARIN WERE ADMINISTRATED TO THE PATIENT. TRANSEPTAL PUNCTURE WAS PERFORMED AND ANOTHER 3CC OF HEPARIN WERE ADMINISTRATED. THE WAS INSERTION WAS MADE AND THEN THE WAS DILATOR WAS REMOVED AND FLUSHED. AT THAT TIME, A THREAD LIKE THROMBUS LIKE MATERIAL WAS EXPELLED TOGETHER WITH BUBBLES, AND ITS MOVEMENT WAS CONFIRMED ON ECHOCARDIOGRAPHY. IT APPEARED AND DISAPPEARED ONLY FROM A SINGLE ANGLE, AND ACCORDING TO THE PHYSICIAN, ITS APPEARANCE DIFFERED FROM THAT OF A TYPICAL THROMBUS, IT WAS NOT VISIBLE FROM OTHER ANGLES. GRADUAL DISAPPEARANCE WAS CONFIRMED ON ECHOCARDIOGRAPHY. AS IT HAD COMPLETELY DISAPPEARED, THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED. AFTER REGAINING CONSCIOUSNESS FROM ANESTHESIA, THE PATIENT SHOWED NO SIGNIFICANT CHANGES. THERE WERE NO ADVERSE EVENTS. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Air Embolism; Thrombosis/Thrombus

  MAUDE report 24649502 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED A HEMOSTATIC VALVE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD SINGLE CURVE ACCESS SYSTEM (WAS) WAS SELECTED FOR USE. THE WAS WAS PARTIALLY ADVANCED WHEN THE PHYSICIAN NOTICED THE SHEATH WAS LEAKING BLOOD AND THE HUB WAS CRACKED. APPROXIMATELY 20 CC OF BLOOD WAS LOST AND NO INTERVENTION WAS REQUIRED. THE PHYSICIAN EXCHANGED THE WAS SHEATH FOR A NEW ONE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24634303 ↗
• InjurySep 10, 2025Adverse 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 (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD SINGLE CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY WITH WAS SHEATH BEING ADVANCED OVER THE RF PIGTAIL WIRE. PIGTAIL CATHETER WAS INSERTED AND PHYSICIAN ASKED IF IT WAS TIME FOR BLOOD TO BE DRAWN FOR ACTIVE CLOTTING TIME (ACT). AT THIS POINT, ANESTHESIA INFORMED THE PHYSICIAN THAT HEPARIN HAD NOT BEEN GIVEN. HEPARIN WAS IMMEDIATELY ADMINISTERED TO THE PATIENT. THE PHYSICIAN PAUSED TO ALLOW FOR HEPARIN TO TAKE EFFECT, AND IT WAS NOTICED THAT A THROMBUS HAD FORMED ON THE WAS SHEATH AND PIGTAIL CATHETER. THE ENTIRE SYSTEM WAS PULLED BACK TO THE RIGHT SIDE, THE PIGTAIL RF WIRE WAS REINSERTED, AND THE WAS SHEATH AND PIGTAIL CATHETER WERE TAKEN OUT OF THE PATIENT'S BODY. THE PHYSICIAN FLUSHED THE ENTIRE SYSTEM AND REINSERTED THE WAS SHEATH. THE PHYSICIAN WAS ABLE TO RECROSS THE SEPTUM AND THE PROCEDURE WAS PERFORMED NORMALLY. ACT AFTER HEPARIN DOSE WAS 221 SECONDS, AT WHICH TIME THE PHYSICIAN ORDERED AN ADDITIONAL DOSE OF HEPARIN. THE PHYSICI

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23016303 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE WDS. THE 27MM CLOSURE DEVICE WAS NOTED TO BE TOO LARGE FOR THE APPENDAGE, A 24MM CLOSURE DEVICE WAS OPENED AND INSERTED. WHILE THIS CLOSURE DEVICE FIT THE APPENDAGE IT WAS NOTED THAT THERE WAS AT LEAST 1/2 OF A MITRAL SHOULDER AND THE PHYSICIAN DECIDED TO ATTEMPT A 20MM DEVICE. THE 24MM DEVICE WAS REMOVED AND THE PIGTAIL WIRE WAS REINSERTED INTO THE APPENDAGE TO GAIN THE REQUIRED DEPTH FOR DEPLOYMENT. THE 20MM WAS PREPPED APPROPRIATELY AND THE PIGTAIL WAS THEN REMOVED. IT WAS NOTED AT THIS TIME THAT THE WAS APPEARED TO DIVE DEEPER INTO THE APPENDAGE. THE 20MM CLOSURE DEVICE WAS INSERTED AND A CONTRAST INJECTION WAS PERFORMED. DURING THE CONTRAST INJECTION IT WAS NOTED THAT CONTRAST WAS FILLING INTO THE PERICARDIUM. THE 20MM CLOSURE DEVICE WAS LEFT IN THE APPENDAGE WHILE A PERICARDIOCENTESIS WAS PERFORMED WHICH REMOVED 600ML OF FLUID. WHEN THE PATIEN

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 22843599 ↗
• 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 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. 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 INFORMA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22590341 ↗
• 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 22590314 ↗
• 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 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 22589343 ↗
• InjuryJun 18, 2025Adverse 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 FXD CURVE ACCESS SYSTEM (WAS) AND A 20MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. PRIOR TO STARTING THE PROCEDURE, A SMALL EFFUSION WAS NOTED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). AS THE PHYSICIAN REMOVED THE WAS SHEATH FROM THE PATIENT'S BODY THE EFFUSION WAS ASSESSED AND FOUND TO BE SLIGHTLY LARGER THAN THE START. THE 20MM CLOSURE DEVICE WAS ATTEMPTED TO BE IMPLANTED, BUT THE PATIENT'S APPENDAGE WAS NOT SUITABLE FOR THE CLOSURE DEVICE, SO THE PATIENT DID NOT RECEIVE A CLOSURE DEVICE. THE PATIENT WAS GIVEN PROTAMINE AND PERICARDIOCENTESIS WAS DONE AFTER THE GROIN CLOSURE. A FOLLOW-UP SURFACE ECHO WAS PERFORMED PRIOR TO DISCHARGE AND EFFUSION WAS BACK TO BASELINE. THE PATIENT WAS DISCHARGED HOME AND IS FULLY RECOVERED.

  Patient problems: Pericardial Effusion

  MAUDE report 22286396 ↗
• MalfunctionJan 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ACCESS SYSTEM BECAME KINKED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE DOUBLE CURVE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED THREE (3) TIMES BUT DID NOT MEET RELEASE CRITERIA. THE PHYSICIAN DECIDED TO REPLACE THE WAS WITH A NEW SINGLE CURVE WAS. THE NEW WAS POSITIONED IN THE LAA, AND THE PHYSICIAN THEN DEPLOYED A NEW 24MM CLOSURE DEVICE. THE CLOSURE DEVICE WAS DEPLOYED FOUR (4) TIMES BUT DID NOT MEET RELEASE CRITERIA. DURING ONE OF THE DEPLOYMENTS THE WAS BECAME KINKED. THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE USING THE KINKED WAS. A NEW 20MM CLOSURE DEVICE WAS THEN DEPLOYED TWICE IN THE LAA OF THE PATIENT. DURING THE SECOND DEPLOYMENT FLUOROSCOPY IMAGING SHOWED THAT THE SYSTEM SHIFTED INSIDE THE PATIENT AND PERFORATED THE LAA. THE PERFORATION RESULTED IN A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS DRAINING ONE (1) LITER OF BRIGHT RED BLOOD WHICH WAS THEN GIVEN BACK TO THE PATIENT. THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126916 ↗
• InjurySep 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE INTERIOR POLYTETRAFLUOROETHYLENE (PTFE) LINER DELAMINATED FROM THE SHEATH. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. AFTER DEPLOYMENT OF THE WDS, AN ECHO DENSITY WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). IT WAS ASSUMED TO BE A THROMBUS; HOWEVER, IT WAS AN ABNORMAL APPEARING THROMBUS. ASPIRATION OF THE SHEATH WAS PERFORMED WITHOUT SUCCESS. A WATCHMAN CLOSURE DEVICE WAS IN PLACE AT THE TIME BUT WAS SUBOPTIMAL POSITIONING AND A RECAPTURE WAS NECESSARY. AFTER RECAPTURE, THE WDS WAS REMOVED FROM THE PATIENT BODY AND WAS UNREMARKABLE. FURTHER ASPIRATION OF THE WAS SHEATH WAS PERFORMED WITHOUT ANY EVIDENCE OF THROMBUS. AT THIS POINT THE ECHO DENSITY WAS NO LONGER OBSERVED ON TEE. UPON ATTEMPTING TO ADVANCE A NEW WDS, RESISTANCE WAS FELT BY THE PHYSICIAN, AND THE DECISION WAS MADE TO REMOVE THE WAS SHEATH FROM THE BODY. IN TROUBLESHOOTING, THE DILATOR WAS REINTRODUCED INTO THE SHEATH WITH FORCE AND A CLEAR PLASTIC APPEARING SUBSTANCE WAS EXPELLED FROM THE SHEATH THAT APPEARED TO BE ATTACHED TO THE INTERIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238485 ↗
• InjuryJul 25, 2024Adverse 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 CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. THE PHYSICIAN WAS ATTEMPTING TO PERFORM THE TRANSEPTAL PUNCTURE (TSP) WITH A NON-BOSTON SCIENTIFIC (BSC) BRK NEEDLE AND NON-BSC SRO SHEATH. THE PHYSICIAN FELLOW WAS ATTEMPTING TSP AND WAS HAVING TROUBLE VISUALIZING WHERE THE TIP OF THE SHEATH/DILATOR WAS ON THE SEPTUM. AT THIS POINT, THE IMPLANTING PHYSICIAN TOOK OVER AND COULD SEE ON ECHOCARDIOGRAPHY THAT TSP DEVICE WAS ON THE SEPTUM, BUT NOT ON THE FOSSA OVALIS AND WAS ANTERIOR. THE NON-BSC BRK NEEDLE WAS THEN ADVANCE THROUGH THE SEPTUM. THE ECHO IMAGER AND THE BSC REP VERBALIZED THAT THEY WERE UNSURE THAT THIS WAS A SAFE OR OPTIMAL POSITION FOR TSP. THE PHYSICIAN CONTINUED TO ADVANCE THE NON-BSC SRO SHEATH FORWARD. THE PHYSICIAN REMOVED THE NON-BSC BRK NEEDLE, ADVANCED AN AMPLATZ SUPER STIFF WIRE THAT WENT OUTSIDE THE CARDIAC SILHOUETTE, AND ADVANCED THE WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) SHEATH OVER THE AMPLATZ SUPER STIFF WIRE WITHOUT CONFIRMING WITH THE ECHO PHYSICIAN THAT IT WAS IN A VEIN. THE IMPLANTING PHYSICIAN ASKED FOR AN EFFUSION CHECK AT THIS TIME. THERE WAS A GROWING PERICARDIAL EFFUSION NOT

  Patient problems: Cardiac Arrest; Cardiac Perforation; Pericardial Effusion

  MAUDE report 19827161 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING. VENOUS ACCESS WAS OBTAINED AND TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED THROUGH A THICK SEPTUM USING A SINGLE CURVE WATCHMAN ACCESS SHEATH (WAS). A PIGTAIL CATHETER WAS INSERTED INTO THE LAA. HEPARIN HAD BEEN ADMINISTERED. A 20MM WATCHMAN FLX CLOSURE DEVICE AND DELIVERY SYSTEM (WD) WAS ADVANCED AND POSITIONED AT THE LAA THEN SUBSEQUENTLY DEPLOYED. A THROMBUS WAS NOTED TO HAVE FORMED AND ATTACHED TO THE WAS. IT WAS NOTED THE ACTIVATED CLOTTING TIME (ACT) WAS HIGH OUT OF RANGE OVER 400. RELEASE CRITERIA WAS MET AND THE WATCHMAN FLX CLOSURE DEVICE WAS RELEASED AND IMPLANTED. THE PHYSICIAN DECIDED TO REMOVE THE WAS AND NO PATIENT ADVERSE EFFECTS WERE NOTED. THE PROCEDURE WAS CONCLUDED. IT WAS FURTHER REPORTED THE PATIENT WAS DISCHARGED HOME IN A ROUTINE FASHION POST PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19756725 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PERFORATION AND PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED IN THE PATIENT, AND IT APPEARED TO BE IN THE PERICARDIAL SPACE WITH LITTLE TO NO COMPRESSION. THE PHYSICIAN BELIEVES THAT THE WAS PERFORATED THE BACK WALL OF THE LAA PRIOR TO THE WDS INSERTION. A PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE EFFUSION AND THE PATIENT WAS GIVEN A BLOOD TRANSFUSION. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM WHERE ALL THE DEVICES WERE REMOVED FROM THE PATIENT AND THE LAA WAS LIGATED. THE PATIENT IS STABLE FOLLOWING THIS EVENT AND EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19731334 ↗
• MalfunctionJul 10, 2024Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DEVICE DAMAGE OCCURRED. THE PROCEDURE WAS ABORTED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. IT WAS NOTED WHEN PREPARING THE SINGLE CURVE WATCHMAN FXD ACCESS SYSTEM (WAS) OUTSIDE OF THE PATIENT, THERE WAS RESISTANCE ENCOUNTERED WHEN INSERTING THE DILATOR INTO THE SHEATH AND THE DILATOR BECAME DEFORMED. THE HEMOSTATIC VALVE WAS KEPT OPEN ON THE WAS AND THE DILATOR WAS ABLE TO BE INSERTED WITH A GOOD AMOUNT OF FORCE. THE WAS WAS INSERTED INTO THE BODY AND INTO THE LEFT ATRIUM OVER A NON-BOSTON SCIENTIFIC (BSC) WIRE. THE NON-BSC WIRE AND DILATOR WAS REMOVED. UPON TRYING TO INSERT THE 24MM WATCHMAN FLX DELIVERY SYSTEM AND CLOSURE DEVICE (WDS), THERE WAS RESISTANCE ENCOUNTERED MULTIPLE TIMES. THERE WAS NOT ANOTHER WAS AVAILABLE FOR USE, SO THE PROCEDURE WAS ABORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712275 ↗
• DeathJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED IN THE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE ICE CATHETER AND WAS. THE PHYSICIAN MANIPULATED THE WAS DUE TO THE EASE OF ASPIRATION THEY NOTED. THE PHYSICIAN THEN REMOVED THE WAS CATHETER AND REFLUSHED THE DEVICE BEFORE REINSERTING IT BACK INTO THE PATIENT. AT THIS MOMENT. THE PATIENT HAD A LARGE AUDIBLE GASP AND THE ANESTHESIOLOGIST NOTED THAT THE PATIENT WAS NOT BREATHING. THE PATIENT WAS INTUBATED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. CPR WAS PERFORMED FOR TEN (10) MINUTES, BUT THE PATIENT'S PULSE NOR RESPIRATION RETURNED. THE PATIENT DID NOT RECOVER, AND THE PATIENT DIED DUE TO THE RESPIRATORY ARREST.

  Patient problems: Cardiac Arrest; Respiratory Arrest

  MAUDE report 19532086 ↗
• InjuryApr 9, 2024Adverse 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 CLOSURE PROCEDURE WAS BEING PERFORMED. THE PHYSICIAN WAS ATTEMPTING TO PERFORM THE TRANSEPTAL PUNCTURE (TSP) WITH THE VERSA CROSS CONNECT SYSTEM AND A WATCHMAN ACCESS SYSTEM (WAS) VIA INTRACARDIAC ECHO (ICE) IMAGING. DURING THE TSP ATTEMPT, THE PHYSICIAN NOTED THAT THE PATIENT HAD DEVELOPED A PERICARDIAL EFFUSION AND NOTED A PERFORATION IN THE PERICARDIUM. THE PHYSICIAN MADE THE DECISION TO ABORT THE WATCHMAN PROCEDURE AND ADMINISTERED PROTAMINE. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED THE NEXT DAY. THE PROCEDURE WILL BE REATTEMPTED IN A FEW WEEKS.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19073124 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEART BLOCK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS), A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS), AND VERSACROSS CONNECT SYSTEM. FOLLOWING THE REMOVAL OF THE VERSACROSS DILATOR, ST ELEVATION WAS NOTED AND 2:1 HEART BLOCK OCCURRED. MEDICATION WAS ADMINISTERED AND A TEMPORARY PACEMAKER WAS PLACED. A CORONARY ANGIOGRAM IDENTIFIED DIMINISHED RIGHT VENTRICLE FUNCTION WITH NO EVIDENCE OF AN AIR EMBOLISM. THE PATIENT STABILIZED AND CARDIAC FUNCTION WAS RESTORED. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED, AND THE PROCEDURE CONCLUDED. DURING RECOVERY, THE PATIENT PASSED ALL NEUROLOGICAL EXAMINATIONS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED ONE DAY POST INDEX PROCEDURE.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 18327143 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDWATCH THAT THERE WAS AN AIR EMBOLUS, AND THE PATIENT WENT INTO CARDIAC ARREST. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN INSERTED THE WAS INTO THE PATIENT AND POSITIONED IT INTO THE LAA. AT THIS TIME, IT WAS NOTED THAT THERE WAS AN AIR EMBOLISM IN THE PATIENT. THE PATIENT WENT INTO CARDIAC ARREST AND NEEDED TO BE RESUSCITATED. THE PATIENT RECOVERED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT TO RECOVER FROM THIS EVENT. MEDWATCH# MW5146669.

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 18065061 ↗
• InjuryAug 4, 2023Adverse 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 VERSACROSS CONNECT WAS USED WITH A WATCHMAN FXD ACCESS SYSTEM (WAS) FOR THE TRANS-SEPTAL PUNCTURE (TSP). THE VERSACROSS WIRE WAS PLACED INTO THE LAA AND THE WAS WAS ADVANCED TO THE OSTIUM OF THE LAA. A CONTRAST INJECTION WAS PERFORMED AND A WATCHMAN CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS SELECTED AND PREPARED. THE VERSACROSS WIRE WAS REMOVED. THROMBOSIS STRANDS WERE THEN IDENTIFIED IN THE LAA AT THE TIP OF THE WAS VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. ASPIRATION WAS PERFORMED THROUGH THE WAS UNTIL NO FURTHER THROMBUS WAS OBSERVED. SEVERAL STRANDS OF THROMBUS WERE SEEN IN THE SYRINGE AND THE WAS WAS REMOVED. A NEW WAS WAS UTILIZED, TSP WAS RE-PERFORMED AND A WDS WAS SUCCESSFULLY DEPLOYED, RELEASED, AND IMPLANTED IN THE INTENDED LOCATION. POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED, AND NO ISSUES WERE NOTED. THE PATIENT WAS DISCHARGED SAME DAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17460211 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE PROCEDURE, A TRACE PE WAS NOTED. A VERSACROSS CONNECT SYSTEM WAS UTILIZED FOR TRANS-SEPTAL PUNCTURE (TSP). THE PHYSICIAN CROSSED THE SEPTUM POSTERIORLY AND MID. AFTER CROSSING THE SEPTUM, THE PHYSICIAN WAS UNABLE TO SEE THE WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) SHEATH IN THE LEFT ATRIUM (LA) DUE TO IMAGING AND SMALL SIZE OF THE LA. ADDITIONALLY, THE PHYSICIAN WAS UNABLE TO GET THE PIGTAIL INTO THE LAA. THE PHYSICIAN PULLED EVERYTHING BACK INTO THE RIGHT ATRIUM (RA) WITH PLAN TO PERFORM A MORE OPTIMAL TSP. THE PRE-EXISTING TRACE PE WAS EVALUATED AND APPEARED TO BE UNCHANGED. TSP WAS EVALUATED AND APPEARED TO BE POSTERIOR AND ANGLED POSTERIOR IN THE SEPTUM. THE PHYSICIAN WAITED 4 MINUTES TO MONITOR THE BASELINE TRACE PE, AND AGAIN, IT APPEARED TO BE UNCHANGED. PHYSICIAN ATTEMPTED TO RE-PERFORM TSP. WHEN DROPPING DOWN TO EVALUATE THE TENTING, THE PE WAS NOTED TO BE GROWING ALONG THE RA TO THE RIGHT VENTRICLE AND LEFT VENTRICLE. THE PATIENT WAS STABLE, HOWEVER THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE OUT OF CAUTION. HEPARIN WAS REVERSED AND TH

  Patient problems: Pericardial Effusion

  MAUDE report 17261659 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEMATOMA OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) DOUBLE CURVE WAS INSERTED. THE PHYSICIAN DECIDED TO EXCHANGE FOR A WAS SINGLE CURVE. DURING THE EXCHANGE THE PHYSICIAN WAS HOLDING MANUAL COMPRESSION ON THE GROIN AND THE EXCHANGE WIRE KINKED. DURING INSERTION OF THE WAS SINGLE CURVE A HEMATOMA WAS OBSERVED AND NOTED TO BE GROWING. TO ACHIEVE HEMOSTASIS, PROTAMINE WAS ADMINISTERED, AND MANUAL COMPRESSION WAS APPLIED TO THE SITE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED.

  Patient problems: Hematoma

  MAUDE report 17077784 ↗
• InjuryMar 7, 2023Adverse 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 AND A SINGLE CURVE WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) WAS INTRODUCED INTO THE LEFT ATRIUM FOLLOWING TRANSSEPTAL PUNCTURE. A PIGTAIL CATHETER WAS INSERTED INTO THE WAS, AND CONTRAST WAS INJECTED WITH STAINING NOTED IN THE PERICARDIUM. A TRIVIAL PERICARDIAL EFFUSION WAS NOTED. THE PROCEDURE WAS ABORTED DUE TO SEEING THE CONTRAST DYE IN THE PERICARDIAL SPACE AND REPEAT TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED. NO PERICARDIAL EFFUSION WAS NOTED 1 HOUR POST PROCEDURE. THE PATIENT HAD A TOTAL OF 5 ECHOCARDIOGRAMS PERFORMED AND ALL WERE NORMAL. THE PATIENT WAS HOSPITALIZED FOR FURTHER OBSERVATION AND WAS LATER DISCHARGED HOME.

  Patient problems: Pericardial Effusion

  MAUDE report 16498054 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ASYSTOLE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD SINGLE CURVE ACCESS SYSTEM (WAS) WAS INSERTED. AS THE DILATOR WAS ADVANCED TO THE SEPTUM, THE PATIENT WENT INTO ASYSTOLE. CARDIOPULMONARY RESUSCITATION (CPR) WAS THEN PERFORMED ON THE PATIENT, AND EXTERNAL ELECTRICAL PACING OF THE HEART WAS CONDUCTED. NORMAL RHYTHM WAS REESTABLISHED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED, AND A THROMBUS WAS IDENTIFIED DEEP IN THE LAA. THE PROCEDURE WAS THEN ABORTED DUE TO THE IDENTIFIED THROMBUS. THE PATIENT WOKE UP FROM THE PROCEDURE AND RESPONDED TO INITIAL COMMANDS. HOWEVER, THE PATIENT REMAINED HOSPITALIZED WITH PULMONARY EDEMA. NO FUTURE PLANS FOR LAA CLOSURE WERE PLANNED.

  Patient problems: Asystole; Pulmonary Edema

  MAUDE report 16255088 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT'S LAA ANATOMY WAS POSTERIOR AND INFERIOR WITH CHICKEN WING CONFIGURATION. TRANS-SEPTAL PUNCTURE WAS PERFORMED MID-POSTERIOR. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND COMPUTED TOMOGRAPHY (CT) MEASUREMENTS SUGGESTED SIZING FOR A 24MM WATCHMAN FLX CLOSURE DEVICE AND DELIVERY SYSTEM (WDS). A WATCHMAN FXD ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WDS WAS PREPARED AND INSERTED. OVER FIVE DEPLOYMENTS AND PARTIAL RECAPTURES WERE PERFORMED BEFORE REMOVAL OF THE 24MM WDS. A 20MM WDS WAS THEN PREPARED AND INSERTED. THE 20MM WDS REACHED A MORE OPTIMAL POSITION THAN THE PREVIOUS 24MM WDS, HOWEVER IT DID NOT MEET POSITION, ANCHOR, SIZE, SEAL (PASS) CRITERIA AND WAS THEREFORE REMOVED. THE WAS REPOSITIONED AND A NEW 24MM WDS WAS PREPARED AND INSERTED. AS THE 24MM WDS WAS BEING INSERTED, THE WAS AGGRESSIVELY SPUN OUT OF THE DESIRED LOCATION AND THE DECISION WAS MADE TO ABORT THE PROCEDURE. ECHOCARDIOGRAM THEN REVEALED A LARGE PE. AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGERY. A 3

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 16134038 ↗