BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY 2

    MDR report key: 86516 · Received July 5, 1996

    Report

    Report Number
    86516
    Event Type
    Injury
    Date Received
    July 5, 1996
    Date of Event
    January 5, 1996
    Report Date
    January 25, 1996
    Manufacturer
    MANSFIELD BOSTON SCIENTIFIC CORP
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA OF LAD, A PIECE OF THE BALLOON CATHETER WAS DISLODGED AND BROKE OFF. CARDIOLOGIST UNABLE TO RETRIEVE WITH ASSISTANCE OF CARDIOVASCULAR SURGEON. CATHETER HAD TO BE SURGICALLY REMOVED FROM CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY 2 RAPID EXCHANGE PTCA CATHETER LOX MANSFIELD BOSTON SCIENTIFIC CORP 14-9000 215155

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening