BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 437284 · Received January 10, 2003

    Report

    Report Number
    MW1027210
    Event Type
    Death
    Date Received
    January 10, 2003
    Date of Event
    December 29, 2002
    Report Date
    January 10, 2003
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS HISTORY OF CABG: BYPASS GRAFT 15 YEARS AGO. NOW WITH "SEVERE RE-STENOSIS OF STENT." HAD PTCA TO OPEN STENT. PHYSICIAN FELT RESISTANCE WHEN USING BALLOON. REMOVED BALLOON, STARTED USING CUTTER BALLOON. CUTTER BALLOON RUPTURED AND BECAME ENTRAPPED IN VESSEL. CARDIOTHORACIC SURGEON CONSULTED AND PT WAS TAKEN TO SURGERY TO HAVE FRAGMENTS OF DEVICE REMOVED. THORACIC SURGEON ABLE TO RETRIEVE BALLOON GUIDEWIRE BUT NOTED, PER SURGEON'S REPORT, "HARDWARE LEFT IN PT," PT WAS REMOVED FROM HEART LUNG MACHINE, BEGAN TO DETERIORATE, WENT INTO V-TACH AND EXPIRED WHILE IN SURGERY. THIS INCIDENT WAS REPORTED TO A REP OF COMPANY THAT WAS ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC 3.25 X 10 CUTTING BALLOON LOX BOSTON SCIENTIFIC B132510 FT0205303

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death