BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN TRUSEAL ACCESS SYSTEM

    MDR report key: 9996670 · Received April 24, 2020

    Report

    Report Number
    2134265-2020-05302
    Event Type
    Death
    Date Received
    April 24, 2020
    Date of Event
    April 3, 2020
    Report Date
    April 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729965718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEATH 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. WHEN GAINING LEFT FEMORAL VENOUS ACCESS AND DOING THE TRANSSEPTAL PUNCTURE, THERE WAS SOME RESISTANCE WHEN PASSING THE WIRE AND SHEATH PAST THE ILIAC ARTERY. IN ORDER TO PREVENT ANY POSSIBLY KINKS WITH THE WATCHMAN DOUBLE CURVE ACCESS SHEATH (WAS), A 16 F SHEATH WAS INSERTED INTO THE GROIN AND THE WAS INSERTED THROUGH THE 16 F SHEATH AND INTO THE LEFT ATRIUM. ONCE GAINING ACCESS INTO THE LEFT ATRIUM, HEPARIN WAS GIVEN. THE WAS AND PIGTAIL WERE POSITIONED INTO THE ANTERIOR LOBE OF THE LAA. THE PIGTAIL WAS REMOVED FROM THE WAS AND THE WAS DID NOT CHANGE POSITION, BUT WAS DEEP IN THE LAA. AS THE 27 MM DEVICE WAS ADVANCED THROUGH THE WAS, IT WAS NOTED THE WAS SHOULD BE PULLED BACK FOR SAFETY. INSTEAD OF PULLING THE WAS BACK OUT OF THE LAA, THE WAS ADVANCED FURTHER AND ANTERIORLY. IT WAS BELIEVED THE WAS PERFORATED THE LAA, THE PHYSICIAN HAD THE ECHOCARDIOGRAPHER SEARCH FOR AN EFFUSION WHILE THEY SIMULTANEOUSLY CONNECTED THE MANIFOLD TO THE WAS. AN EFFUSION WAS FOUND AND THE WAS TIP WAS OUTSIDE OF THE LAA. SINCE THE DEVICE WAS ALREADY WITHIN THE WAS, THE PHYSICIAN WANTED TO PULL THE WAS BACK AND DEPLOY THE DEVICE IN AN EFFORT TO SLOW THE EFFUSION. THE PHYSICIAN CHOSE TO DEPLOY THE DEVICE AND PROCEEDED TO PERFORM A PERICARDIOCENTESIS IMMEDIATELY. WHILE TAPPING THE PATIENT, A CALL FOR CT SURGERY BACKUP WAS MADE. THE ON CALL SURGEON WAS AT HOME APPROXIMATELY 20-25 MINUTES AWAY. THERE WERE TWO UNITS OF BLOOD IN THE ROOM THAT WERE IMMEDIATELY SET UP ALONG WITH FLUIDS. ECHO SHOWED THE EFFUSION GROWING AND THE PATIENTS HEART WAS BEGINNING TO TAMPONADE. THE AMOUNT OF BLOOD WITHDRAWN FROM THE PERICARDIUM IS UNKNOWN DUE TO QUICKLY WITHDRAWING BLOOD AND PERFORMING AUTO TRANSFUSIONS. WHEN THE PATIENT WAS STABLE ENOUGH, THE DEVICE WAS CHECKED ON ECHO TO MAKE SURE IT WAS IN THE LAA. IT WAS SLIGHTLY DISTAL TO THE OSTIUM WITH A SMALL LEAK SHOWN ON ECHO, AND WHAT APPEARED TO BE ADEQUATE COMPRESSION VIA FLUOROSCOPY SHOWING THE DEVICE SHAPE. THE DEVICE WAS RELEASED OFF THE CORE WIRE AND ONCE THE WAS/WDS SYSTEM WAS REMOVED FROM THE LEFT SIDE OF THE HEART, PROTAMINE WAS GIVEN. BECAUSE THE BLOOD IN PERICARDIUM STARTED TO CLOT, THE PATIENTS HEART FUNCTION AND BLOOD PRESSURE DECREASED OVER TIME. CPR WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENTS BELLY DISTENDED EXTENSIVELY DUE TO BLEEDING. CARDIOTHORACIC SURGERY ASSESSED THE SITUATION AND IT WAS CHOSEN NOT TO PROCEED WITH SURGICAL INTERVENTION. THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457807 WATCHMAN TRUSEAL ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL DQY BOSTON SCIENTIFIC CORPORATION M635TU70020 0024804605 08714729965718

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death