BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE FLOPPY II

    MDR report key: 165478 · Received April 28, 1998

    Report

    Report Number
    MW1013681
    Event Type
    Malfunction
    Date Received
    April 28, 1998
    Date of Event
    April 21, 1998
    Report Date
    April 28, 1998
    Manufacturer
    GUIDANT CORP. ADVANCED CARDIOVASCULAR SYSTEMS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE WITH STENT PLACEMENT A .014 FLOPPY TIP GUIDE WIRE WAS UTILIZED. WHEN THE ABOVE FLOPPY TIP GUIDE WIRE WAS PLACED THROUGH THE STENT IT BECAME ENTANGLED IN THE STENT AND A PORTION OF THE GUIDE WIRE BROKE OFF IN THE STENT. THIS WAS NOT THE CAUSE OF THE PT'S EMERGENT CORONARY ARTERY BYPASS GRAFT PROCEDURE. THIS REPORT IS JUST AN "FYI" THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE FLOPPY II Implant COATED GUIDE WIRE DQX GUIDANT CORP. ADVANCED CARDIOVASCULAR SYSTEMS 0.014 8011351

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 3.0 HC COBRA STENT