WATCHMAN™ TruSeal™ Access System M635TU70010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729965701), received between Dec 4, 2018 and Aug 9, 2023 — classified as 18 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning 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-2431-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE WAS AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED IN THE PATIENT AND SUCCESSFULLY IMPLANTED IN THE LAA. POST CLOSURE DEVICE RELEASE IT WAS DISCOVERED THAT THERE WAS A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE AROUND THE RIGHT VENTRICLE. THE PATIENT WAS GIVEN PROTAMINE POST PROCEDURE AND WAS BROUGHT TO RECOVERY. THE PATIENT WAS THEN BROUGHT BACK TO THE LAB SO THE PHYSICIAN COULD PERFORM A PERICARDIOCENTESIS. THE PHYSICIAN BELIEVES THAT THE PERICARDIAL EFFUSION WAS A RESULT OF THE WAS DURING THE TRANSSEPTAL INSERTION. THE PATIENT IS RECOVERING AND EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 17493461 ↗
• InjuryJun 30, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AFTER THE TRANSEPTAL PUNCTURE WAS PERFORMED AND THE TRANSEPTAL SHEATH WAS EXCHANGED FOR A SINGLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS), THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE WAS AND PIGTAIL INTO THE LAA. IT TOOK A NUMBER OF MINUTES AND AT THAT TIME HEPARIN WAS GIVEN TO THE PATIENT. A FEW MINUTES LATER ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING, A SUSPECTED THROMBUS WAS NOTED ATTACHED TO THE PIGTAIL AND/OR THE ACCESS SYSTEM. THE PIGTAIL WAS REMOVED AND THROMBUS WAS NOTED ON IT. THE TEE DID NOT SHOW ANY ADDITIONAL SIGNS OF THROMBUS ON THE SHEATH, WHICH HAD REMAINED IN THE BODY. THE PIGTAIL WAS FLUSHED THOROUGHLY AND REINSERTED. ACTIVATED CLOTTING TIME (ACT) WAS CHECKED AND NOTED TO BE GREATER THAN 200 SECONDS AND CLIMBING. THE SINGLE CURVE WAS WAS EXCHANGED FOR A DOUBLE CURVE WAS. THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER ISSUE AND A WATCHMAN FLX LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14880467 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED. AFTER CROSSING THE INTERATRIAL SEPTUM WITH THE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS), THE SHEATH WAS INADVERTENTLY PULLED BACK INTO THE RIGHT ATRIUM WHEN REMOVING THE GUIDEWIRE AND A CLOT FORMED ON THE WAS SHEATH. THE WAS SHEATH WAS REMOVED AND FLUSHED. A NEW TRANSSEPTAL PUNCTURE WAS PERFORMED AND AFTER INSERTING THE WAS SHEATH INTO THE RIGHT ATRIUM, A CLOT FORMED AGAIN. ACCORDING TO THE PHYSICIAN, THE ROUGHNESS OF THE WAS SHEATH WAS MOST LIKELY THE CAUSE OF THE THROMBUS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13660524 ↗
• InjuryFeb 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR IN THE DEVICE AND AN AIR EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT. THE PIGTAIL CATHETER WAS TAKEN OUT OF THE PATIENT AND THE WDS WAS THEN INSERTED INTO THE WAS. WHILE INSERTING THE WDS AIR WAS SEEN IN THE WAS WHICH THEN WAS PUSHED OUT INTO THE LAA OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE AIR EMBOLISM, BUT IT MOVED TO THE LEFT VENTRICLE. 200MCG OF NITRO AND 100% FIO2 WAS GIVEN TO THE PATIENT TO TREAT THE AIR EMBOLISM. AFTER THIS TREATMENT THE AIR RESOLVED AND THE PROCEDURE WAS CONTINUED. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY WITH THE CLOSURE DEVICE BEING IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO OTHER COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE. 2 HOURS POST PROCEDURE THE PHYSICIAN WAS IMAGING THE CLOSURE DEVICE AND LAA OF THE PATIENT WHEN IT WAS NOTED THAT THERE WAS A PERICARDIAL EFFUSION IN THE LEFT VENTRICLE. THE PATIENT HAD SOME CHEST PAIN AND THERE WAS A SMALL FLUID COLLECTION. NO

  Patient problems: Air Embolism

  MAUDE report 13508366 ↗
• InjuryDec 6, 2021Positioning Problem; Positioning Problem

  THE PATIENT WAS ENROLLED IN (B)(6) STUDY ON (B)(6) 2021 WITH PATIENT IDENTIFIER (B)(6). PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) AND APIXABAN (10 MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE TRANS-SEPTAL PUNCTURE (TSP) WAS PERFORMED AND A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS ADVANCED. HOWEVER, THROUGH ASSESSMENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND INTRAOPERATIVE ANGIOGRAPHY, THERE WERE NO SUITABLE WAS SHEATH ALIGNMENTS TO THE LAA OSTIUM. THE PHYSICIANS ATTEMPTED WITH A SECOND WAS, HOWEVER WAS AGAIN, UNSUCCESSFUL. THE PROCEDURE WAS ABORTED. TEE CONFIRMED THERE WERE NO ACUTE THROMBUS IN THE LAA. ON THE SAME DAY, POST-PROCEDURE ATTEMPT, WHILE IN RECOVERY, THE PATIENT EXPERIENCED SEVERE PLEURITIC BACK PAIN AND RIGHT FLANK PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. URGENT BEDSIDE ECHOCARDIOGRAPHY WAS PERFORMED WHICH REVEALED THERE WAS NO PERICARDIAL EFFUSION. THE PATIENT WAS TREATED WITH A DOSE OF TORADAL AND BENADRYL FOR A POSSIBLE PROTAMINE REACTION. CHEST COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WITH CONTRAST REVEALED A LARGE CIRCUMFERENTIAL HEMATOMA AND ACTIVE EXTRAVASATION THINNING FROM THE MEDIAL ASPECT OF TH

  Patient problems: Extravasation; Hematoma; Pain; Vascular Dissection

  MAUDE report 12934214 ↗
• InjuryDec 1, 2021Positioning Problem; Positioning Problem

  THE PATIENT WAS ENROLLED IN THE CHAMPION-AF STUDY ON (B)(6) 2021 WITH PATIENT IDENTIFIER (B)(6). PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) AND APIXABAN (10 MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE TRANS-SEPTAL PUNCTURE (TSP) WAS PERFORMED AND A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS ADVANCED. HOWEVER, THROUGH ASSESSMENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND INTRAOPERATIVE ANGIOGRAPHY, THERE WERE NO SUITABLE WAS SHEATH ALIGNMENTS TO THE LAA OSTIUM. THE PROCEDURE WAS ABORTED. TEE CONFIRMED THERE WERE NO ACUTE THROMBUS IN THE LAA. IT WAS REPORTED THAT A SECOND WAS WAS USED DURING THIS ATTEMPT, BUT NO FURTHER DETAILS ARE KNOWN. ON THE SAME DAY, POST-PROCEDURE ATTEMPT, WHILE IN RECOVERY, THE PATIENT EXPERIENCED SEVERE PLEURITIC BACK PAIN AND RIGHT FLANK PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. URGENT BEDSIDE ECHOCARDIOGRAPHY WAS PERFORMED WHICH REVEALED THERE WAS NO PERICARDIAL EFFUSION. THE PATIENT WAS TREATED WITH A DOSE OF TORADAL AND BENADRYL FOR A POSSIBLE PROTAMINE REACTION. CHEST COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WITH CONTRAST REVEALED A LARGE CIRCUMFERENTIAL HEMATOMA AND ACTIVE EXTRAVASATION THINNIN

  Patient problems: Extravasation; Hematoma; Pain; Vascular Dissection

  MAUDE report 12908469 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT A VESSEL PERFORATION AND HEMATOMA OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE PREPARED. THE WAS INSERTED THROUGH A 16F 40 CENTIMETER SHEATH IN THE GROIN. AFTER AN INITIAL FLUOROSCOPY IMAGE WAS TAKEN WITH THE WAS AND THE PIGTAIL CATHETER, THE PHYSICIAN FOUND THE ANATOMY OF THE PATIENT UNSUITABLE FOR IMPLANTATION. THE ANATOMY WAS SUCH THAT THE IMPLANTABLE DEPTH WAS AT A RIGHT ANGLE FROM THE SHEATH APPROACH. TWO TRANSSEPTAL PUNCTURE LOCATIONS WERE TRIED BUT NEITHER PROVIDED ACCESS TO PROPERLY IMPLANT THE DEVICE. THE SHEATH WAS REMOVED AND THE PATIENT WAS TRANSFERRED TO RECOVERY. WHILE IN RECOVERY THE PATIENT EXPERIENCED CHEST PAIN. SCANS REVEALED BLEEDING IN THE THORACIC AND ABDOMINAL CAVITIES ORIGINATING FROM THE INFERIOR VENA CAVA. THE PATIENT WAS TAKEN OFF ANTICOAGULANTS AND MOVED TO THE POST ANESTHESIA CARE UNIT FOR MONITORING. THE DIRECT CAUSE IS UNCLEAR ACCORDING TO THE PHYSICIAN; HOWEVER, IT WAS ASSUMED THAT A VESSEL TEAR MAY HAVE OCCURRED WHILE REMOVING THE SHEATHS. THERE WERE NO FURTHER REPORTED

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 12647225 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A SINGLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AN OBJECT APPEARING TO BE A MOBILE THROMBUS WAS IDENTIFIED ON THE TIP OF THE WAS VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WHILE THE DEVICE WAS IN THE LEFT ATRIUM. THIS WAS NOTICED AFTER TRANSSEPTAL PUNCTURE AND BEFORE THE PIGTAIL WIRE WAS INSERTED INTO THE WAS. THE PHYSICIAN ASPIRATED BLOOD THROUGH THE WAS, AND SUCCESSFULLY IMPLANTED THE CLOSURE DEVICE. THE PATIENT WAS EXTUBATED POST INDEX PROCEDURE AND WAS DOING WELL POST IMPLANT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12583696 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERFORATION, PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE PROCEDURE, A BASELINE TRIVIAL PERICARDIAL EFFUSION (PE) WAS NOTED TO MEASURE 2-3MM. THE FELLOW PHYSICIAN ATTEMPTED THE INITIAL TRANSSEPTAL PUNCTURE, BUT ACCESS TO THE LEFT SIDE WAS LOST SHORTLY AFTER CROSSING. THE IMPLANTING PHYSICIAN PERFORMED THE SECOND TRANSSEPTAL CROSSING, BUT ENCOUNTERED DIFFICULTY NAVIGATING SAFELY INTO THE VEIN. HE RE-ATTEMPTED FOR A THIRD CROSSING IN A MORE FAVORABLE LOCATION MID-SEPTUM BUT THE WIRE WOULD STILL NOT ENTER THE VEIN. IT WAS THEN DECIDED TO UTILIZE A DIFFERENT NON-BOSTON SCIENTIFIC CORPORATION (BSC) TRANSSEPTAL CROSSING GUIDEWIRE WITH A CURLED TIP WHICH REQUIRED A FOURTH TRANSSEPTAL CROSS AND A SHEATH EXCHANGE. THE FOURTH TRANSSEPTAL CROSS WAS SUCCESSFUL AND ALLOWED THE PHYSICIAN TO NAVIGATE THE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) SINGLE CURVE SHEATH INTO THE LEFT SIDE. A PIGTAIL THEN WENT IN OVER THE GUIDEWIRE AND THE GUIDEWIRE WAS REMOVED. THE PIGTAIL AND WAS SHEATH TIP SLOWLY NAVIGATED INTO THE LAA WHEN THE PHYSICIAN NOTICED A LATERAL PE, NOTABLY LARGER THAN THE INITIAL PE,

  Patient problems: Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 12528209 ↗
• InjurySep 13, 2021Adverse 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. NO PERICARDIAL EFFUSIONS WERE NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM AT THE START OF THE PROCEDURE. THE 24MM WATCHMAN FLX DELIVERY SYSTEM WAS NOT YET TO THE PROXIMAL MARKER BAND OF THE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WHEN A PERFORATION WAS NOTED. A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE OCCURRED. A CONTRAST INJECTION WAS PERFORMED SHOWING THE WAS ADVANCED DISTALLY IN THE LAA. A PERICARDIAL TAP WAS PERFORMED FOLLOWED BY EMERGENT SURGICAL INTERVENTION. THE EMERGENT SURGERY WAS SUCCESSFUL AND THEN THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR POST CARDIAC CARE SINCE THE IMPLANTING HOSPITAL DID NOT HAVE IT. THE PATIENT WAS DOING WELL FROM THE COMPLICATIONS AND SURGICAL REPAIR, BUT HAD SEVERAL OTHER UNKNOWN ISSUES GOING ON.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 12464659 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ST ELEVATION AND A SUSPECTED TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. DURING MANIPULATION OF THE WAS SHEATH, ST ELEVATION WAS NOTED. AN AIR EMBOLISM WAS SUSPECTED BUT AIR WAS NEVER VISUALIZED IN THE DEVICE OR PATIENT. THE PATIENT WAS PLACED ON OXYGEN. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. POST PROCEDURE, THE PATIENT HAD TIA SYMPTOMS BUT A TIA WAS ONLY SUSPECTED BY THE IMPLANTING PHYSICIAN. THE COMPUTED TOMOGRAPHY (CT) SCAN FINDINGS WERE NORMAL. THE ARM AND LEG WEAKNESS THE PATIENT EXPERIENCED WAS RESOLVING. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Non specific EKG/ECG Changes; Transient Ischemic Attack

  MAUDE report 12158863 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A TRUSEAL WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 35MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. A MOBILE THROMBUS HAD FORMED ON THE WAS SHEATH POST DEPLOYMENT AND WAS ASPIRATED UPON RELEASE OF THE DEVICE. POST PROCEDURE, THE PATIENT DEVELOPED SPEECH AND RIGHT ARM WEAKNESS. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND A SMALL CVA WAS CONFIRMED. THE PATIENT WAS MEDICALLY TREATED AND THE THROMBUS DID RESOLVE. THE FOLLOW UP OF THE PATIENT IS ONGOING.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12050756 ↗
• InjuryApr 21, 2021Adverse 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 TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED IN THE LAA. AFTER THE INITIAL CONTRAST INJECTION THROUGH THE PIGTAIL CATHETER WITHIN THE WAS, THE PATIENT EXPERIENCED ST SEGMENT ELEVATION. THE CARDIAC ANESTHESIOLOGIST NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THERE WAS AIR IN THE LAA AND THE LEFT VENTRICLE. THE PHYSICIAN ASPIRATED BACK THROUGH THE WAS TO REMOVE THE AIR AND THEN EXCHANGED THE WAS FOR A NEW ONE. THE PATIENT WAS GIVEN EPINEPHRINE AND THEY STABILIZED. THERE WAS NO ISSUE NOTED WITH THE FIRST WAS UPON EXAMINATION OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SECOND WAS. POST PROCEDURE THE PATIENT WAS ASSESSED AND THERE WERE NO NEUROLOGICAL DEFICITS NOTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 11703370 ↗
• InjuryApr 19, 2021Adverse 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. THE ENTIRE PROCEDURE WAS GUIDED BY INTRACARDIAC ECHOCARDIOGRAM (ICE) NOT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND MULTIPLE WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEMS (WDS) WERE USED. IN THE FIRST THREE DEPLOYMENT ATTEMPTS EACH DEVICE LANDED FAR TOO PROXIMAL AND THE IMPLANTER WAS UNSUCCESSFUL IN ADVANCING THE FLX BALL DEEP ENOUGH TO ELIMINATE A PROMINENT SHOULDER. THE PATIENT WAS UNDER LOCAL ANESTHESIA AND THERE WAS SIGNIFICANT RESPIRATORY VARIATION DURING EACH DEPLOYMENT. ON THE FINAL DEVICE ATTEMPT, THE PHYSICIAN HAD ADVANCED THE WAS, WITH THE PIGTAIL CATHETER, DEEPER THAN IN PREVIOUS ATTEMPTS. A PERFORATION AND SUBSEQUENT PERICARDIAL EFFUSION WAS NOTED ON ANGIOGRAM DURING DEPLOYMENT OF THE FOURTH DEVICE WHILE IN THE FLX BALL STATE. IT IS UNCLEAR IF THE PERFORATION OCCURRED DUE TO RECAPTURE OF THE THIRD DEVICE OR DUE TO THE WAS POSITIONING ON THE FINAL ATTEMPT. THE PHYSICIAN IMMEDIATELY RECAPTURED THE DEVICE AND BEGAN THE PROCESS FOR A PERICARDIOCENTESIS. ULTIMATELY, NO WATCHMAN D

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11690704 ↗
• MalfunctionFeb 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER DEVICE DEPLOYMENT, A KINK WAS NOTED IN THE WAS SHEATH. THE KINK APPEARED TO BE AT THE LIGHT/DARK BLUE TRANSITION. THE DEVICE MET RELEASE CRITERIA AND WAS RELEASED. THE PATIENT DID WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357812 ↗
• InjuryFeb 15, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH A SEVERELY ROTATED HEART. A DOUBLE CURVE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER GOING TRANSSEPTAL AND GETTING THE DOUBLE CURVE WAS SHEATH AND PIGTAIL INTO THE APPENDAGE THEY WERE ABLE TO SEE THAT THE APPENDAGE WAS HEADING IN A DIRECTION THAT WAS OPPOSITE OF TRANSESOPHAGEAL ECHO (TEE). THEY ATTEMPTED TO DEPLOY A 24MM DEVICE, BUT WERE UNSUCCESSFUL. THEY DECIDED THAT THEY WOULD NEED TO CROSS THE SEPTUM IN A DIFFERENT SPOT IN ORDER TO HAVE A CHANCE AT CLOSING THE ANATOMY. THE IMAGES WERE DIFFICULT TO OBTAIN AS THEY WERE UNABLE TO SEE THE SHEATH. THEY CROSSED THE SEPTUM AGAIN AND GOT THE GUIDEWIRE INTO THE UPPER PULMONARY VEIN. WHEN ATTEMPTING TO GET THE SECOND SINGLE CURVE TRUSEAL WAS ACROSS THE SEPTUM THE TORQUE PULLED THE GUIDEWIRE OUT AND BACK INTO THE RIGHT ATRIUM. A SWEEP WAS PERFORMED AFTER BOTH THE FIRST AND SECOND ATTEMPTS AND NO EFFUSION WAS NOTED. A THIRD ATTEMPT WAS DONE MORE SUPERIOR/ANTERIOR AND THEY WERE ABLE TO CROSS. AT THIS POINT THEY WERE

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 11328059 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION AND PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND USED. THE PHYSICIAN PLACED A SINGLE CURVE SHEATH IN THE APPENDAGE AND FLUOROSCOPY REVEALED PERFORATION AT THE ROOF OF THE LAA. PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT WAS TAPPED ON THE TABLE AND A CELL SAVER WAS SET UP. THE EFFUSION WAS STABILIZED AND THE PATIENT WAS MOVED TO INTENSIVE CARE UNIT. HOWEVER, THE PATIENT STARTED BLEEDING AND WAS TRANSFERRED TO CARDIOTHORACIC SURGERY. THE PATIENT WAS DISCHARGED FROM SURGERY AND REMAINED STABLE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 10447920 ↗
• MalfunctionAug 7, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. 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 PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE CLOSURE DEVICE WAS IMPLANTED IN THE LAA OF THE PATIENT. THE PROCEDURE WENT WELL AND THERE WERE NO COMPLICATIONS THAT WERE REPORTED. POST PROCEDURE IT WAS NOTED THAT THE TIP OF THE ACCESS SHEATH WAS DAMAGED. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381192 ↗
• MalfunctionOct 11, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT A KINK OCCURRED CAUSING SUBSEQUENT RECAPTURE DIFFICULTY. A WATCHMAN ACCESS SYSTEM (WAS) SINGLE CURVE WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE DELIVERY SYSTEM OF THE FIRST DEPLOYED CLOSURE DEVICE KINKED AND THE CLOSURE DEVICE WAS FULLY RECAPTURED. THE DELIVERY SYSTEM OF THE SECOND CLOSURE DEVICE ALSO KINKED PRIOR TO DEPLOYMENT. THE LAST CLOSURE DEVICE WAS DEPLOYED AND LANDED TOO PROXIMALLY FOR WHICH A FULL RECAPTURE WAS ATTEMPTED. HOWEVER, DIFFICULTY RECAPTURING THE DEVICE WAS MET AND THE ACCESS SYSTEM WAS PULLED ACROSS THE SEPTUM. THE ACCESS SYSTEM WAS NOTED TO HAVE KINKED. VISUAL ANALYSIS OF THE DEVICE SHOWED TISSUE ON THE ANCHORS. POST-PROCEDURE, PATIENT DEVELOPED HYPOTENSION AND A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE WERE DISCOVERED. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 300CC OF BLOOD. PATIENT IS STABLE AND HAS BEEN DISCHARGED HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180067 ↗
• InjuryJul 3, 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 WATCHMAN ACCESS SYSTEM (WAS) SINGLE CURVE AND 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A NON-BSC SYSTEM, A 0.8CM PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS STABLE ALLOWING THE CASE TO CONTINUE. THE 24MM CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH ONE PARTIAL RECAPTURE. PATIENTS BLOOD PRESSURE CONTINUED TO DECREASE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 800 CC OF FLUID FROM THE PERICARDIUM. AT THIS TIME, THE EFFUSION WAS NO LONGER VISIBLE ON ECHOCARDIOGRAM, BUT PATIENTS BLOOD PRESSURE REMAINED LOW. PROTAMINE WAS ADMINISTERED AND THE DRAIN WAS LEFT IN PLACE. A CLOT WAS THEN SEEN FORMING IN THE PERICARDIAL SPACE AND ON THE RIGHT ATRIAL LEAD. THE EFFUSION RESTARTED GROWING AND PRESSURE CONTINUED TO DROP PERIODICALLY. PATIENT WAS TRANSPORTED TO SURGERY FOR A STERNOTOMY AND A PERFORATION WAS FOUND TO THE RIGHT ATRIAL APPENDAGE. PERICARDIAL EFFUSION WAS RESOLVED WITH A SUTURE AND PATIENTS PRESSURE STABILIZED. NO FURTHER COMPLICATIONS WERE REPORTED. PHYSI

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

  MAUDE report 8760053 ↗
• InjuryDec 4, 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 GIVEN DURING THE PROCEDURE. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS 144SEC, SO MORE HEPARIN WAS GIVEN. WHEN THE NON-BSC PIGTAIL CATHETER WAS REMOVED FROM THE WATCHMAN TRUSEAL, IT WAS NOTED THAT THE WHOLE ACCESS SYSTEM WAS FILLED WITH THROMBUS. THEY ASPIRATED AND GAVE MORE HEPARIN WHICH REMOVED ALL OF THE THROMBUS. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH A SUCCESSFUL IMPLANT OF A 24MM WATCHMAN CLOSURE DEVICE. THE PATIENT WOKE UP MOVING ALL EXTREMITIES AND WITH NO SYMPTOMS OF STROKE. THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: Thrombosis

  MAUDE report 8130580 ↗