BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 7327970 · Received March 9, 2018

    Report

    Report Number
    2134265-2018-02047
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 15, 2018
    Report Date
    February 15, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NGV
    UDI-DI
    08714729838203
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS ANTICIPATED PROCEDURAL COMPLICATION AS THE EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2018-02045 AND 2134265-2018-02046. IT WAS REPORTED THAT THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) RANGE AFTER THE TRANSSEPTAL PUNCTURE WAS 241-357 AND A TRACE EFFUSION WAS NOTICED. THE LA PRESSURE WAS 13. A 30MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. DURING PREPARATION, THE CLOSURE DEVICE WAS INADVERTENTLY DEPLOYED ON THE BACK TABLE BY THE TECHNICIAN. THIS DELIVERY SYSTEM WAS NOT USED. ANOTHER 30MM WDS WAS SELECTED. THIS WDS WAS PREPARED AND THEY WERE WATCHING FOR AIR. AIR WAS NOTICED IN THE WDS AS IT WAS BROUGHT TO THE STERILE TABLE. THEY REMOVED THE WDS FROM THE STERILE TABLE AND RE-PREPARED IT AGAIN LOOKING FOR AIR. AIR WAS NOT SEEN, SO IT WAS THEN USED IN THE PROCEDURE. THE WDS WAS ADVANCED INTO THE WATCHMAN ® ACCESS SYSTEM (WAS). THE CLOSURE DEVICE WAS DEPLOYED, BUT NOTED TO BE PROXIMAL SO A FULL RECAPTURE WAS PREFORMED AND THE WDS WAS REMOVED. AN EFFUSION SWEEP WAS PERFORMED AND SAW NO EFFUSION. A THIRD WDS WAS USED AND THIS TIME IT WAS A 27MM WDS. IT WAS PREPARED ON THE BACK TABLE AND THEY WERE LOOKING FOR AIR. THE SEAL OF THE CLOSURE DEVICE WAS BROKEN IN ORDER TO CORRECTLY PREPARE THE DEVICE. DURING PREPARATION OF THIS 27MM WDS, THE ECHO PHYSICIAN SAW A CLOT ON THE RIGHT SIDE OF THE HEART ON THE SEPTUM. THE WAS WAS PULLED BACK ACROSS THE SEPTUM WHILE BEING ASPIRATED WITH A SYRINGE IN AN ATTEMPT TO REMOVE THE CLOT. ONCE THE SHEATH WAS REMOVED THE CLOT WAS NO LONGER SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PATIENT REMAINED STABLE. AS THE WAS WAS REMOVED, IT WAS NOTED THAT THERE WAS A KINK IN THE WAS NEAR THE 33MM MARKER BAND. THE WAS WAS THEN EXCHANGED FOR A SECOND DOUBLE CURVE WAS (LOT 21470960). LAA POSITION WAS REGAINED, THE ¿APPENDOGRAM¿ WAS RETAKEN, AND THE 27MM DEVICE WAS PREPARED. THE FEET OF THE DEVICE WERE MOVED TO ENSURE THEY WERE POSITIONED AT THE DISTAL MARKER BAND OF THE DEPLOYMENT SYSTEM. NO AIR BUBBLES WERE NOTED IN THE WDS. THE WDS WAS ADVANCED INTO THE WAS. AS THE DISTAL MARKER BANDS WERE BEING ALIGNED, AN AIR BUBBLE WAS NOTED IN THE WDS. THE WDS WAS REMOVED AND RE-PREPPED AND THEY WERE AGAIN LOOKING FOR AIR. NO AIR BUBBLES WERE NOTED AND THE FEET OF THE DEVICE WERE ALIGNED WITH THE DISTAL MARKER BAND. THE FEET OF THE CLOSURE DEVICE WERE NOTED TO HAVE MOVED FORWARD PAST DISTAL MARKER BAND WHEN THE WDS WAS BROUGHT TO STERILE TABLE AND THE PHYSICIAN WAS PREPARING TO ADVANCE INTO THE BODY. AIR WAS INTRODUCED WHEN PULLING THE FEET BACK TO MARKER BAND ALIGNMENT, SO THE WDS WAS RE-PREPPED ON THE BACK TABLE. THE PROPERLY ALIGNED WDS WAS THEN INSERTED INTO THE WAS. THE WDS WAS THEN ADVANCED UNTIL THE DISTAL MARKER BANDS WERE ALIGNED AND THE WAS AND WDS WERE NOW SNAPPED AS A SYSTEM. THEY WERE DEEP SEATED IN THE LAA, SO THEY WANTED TO MAKE SURE THEY WATCH THE BACK WALL OF THE LAA UPON DEPLOYMENT. AS THE CLOSURE DEVICE WAS DEPLOYED, IT WAS NOTED THE FEET OF THE DEVICE WERE COMING BACK SLIGHTLY. ONCE THE DEVICE WAS DEPLOYED, IT IMMEDIATELY EMBOLIZED INTO THE LEFT ATRIUM. THE CORE WIRE AND THE DEVICE WERE NOT ATTACHED UPON DEPLOYMENT ALLOWING FOR THE DEVICE TO EMBOLIZE AND MOVE FREELY IN THE LEFT ATRIUM. THE WDS WAS REMOVED AND THE WAS WAS KEPT IN PLACE. THE DEVICE REMAINED IN THE LEFT ATRIUM. THE PATIENT REMAINED STABLE. PRADAXA WAS REVERSED WITH PRAXBIND. A 25MM GOOSE NECK NON-BSC SNARE WAS INSERTED INTO THE SHEATH IN AN ATTEMPT TO SNARE THE DEVICE. AT THE SAME TIME THE, OPERATING ROOM WAS CALLED AND MADE AWARE OF A POTENTIAL EMERGENT CASE. AS THE PHYSICIAN WAS ATTEMPTING TO SNARE THE DEVICE, THE DEVICE BECAME LODGED IN THE MITRAL VALVE ANNULUS WITH THE FABRIC FACING TOWARD THE ATRIUM. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED, DEVELOPING HYPOTENSION. THE TEE WAS MAINTAINED AND THE VIEW OF DEVICE WAS CONTINUOUS. NOREPINEPHERINE AND LEVOPHED WERE STARTED TO HELP MANAGE THE PATIENT¿S BLOOD PRESSURE. RIGHT FEMORAL ARTERIAL ACCESS WAS GAINED VIA A MODIFIED SELDINGER TECHNIQUE, AND A 7F SHEATH WAS PLACED. UNDER FLUOROSCOPIC GUIDANCE, AN INTRA-ARTERIAL BALLOON PUMP (IABP) WAS INSERTED TO ASSIST WITH HEMODYNAMIC INSTABILITY. AUGMENTATION WAS EXCELLENT AT A 1:1 RATIO. THE PATIENT¿S BLOOD PRESSURE IMPROVED MARKEDLY ONCE THE IABP WAS PLACED. THE OPERATING ROOM (OR) WAS NOTIFIED THAT THIS WAS AN EMERGENT PATIENT AND A ROOM WAS PREPARED. THE PATIENT REMAINED STABLE ON CARDIAC SUPPORT. THE CLOSURE DEVICE WAS NOTED TO HAVE MIGRATED TO LEFT VENTRICLE UPON ARRIVAL TO OR. A CARDIOVASCULAR SURGEON REMOVED THE CLOSURE DEVICE, LIGATED THE LAA, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THERE WAS MILD TO MODERATE MITRAL REGURGITATION SEEN ON ECHOCARDIOGRAM AND THE PATIENT WAS BEING WEANED OFF PHARMACOLOGICAL SUPPORT. THE PATIENT WAS STABLE THAT EVENING AND WAS DISCHARGED THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170153 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - GALWAY M635TU20060 0021438522 08714729838203

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R