BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT

    MDR report key: 387051 · Received April 2, 2002

    Report

    Report Number
    2024168-2002-00119
    Event Type
    Malfunction
    Date Received
    April 2, 2002
    Date of Event
    February 8, 2002
    Report Date
    March 8, 2002
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFULLY STENTING A LESION IN THE DIAGONAL, THE STENT DELIVERY SYSTEM (SDS) AND THE GUIDE WIRE WERE REMOVED TOGETHER. IT WAS THEN NOTED THAT THE TIP OF THE GUIDE WIRE APPEARED TO BE AN ABNORMAL DISTANCE (DISTAL) TO THE END OF THE DELIVERY SYSTEM. WHEN THE GUIDE WIRE WAS REMOVED FROM THE DELIVERY SYSTEM, THE GUIDE WIRE COILS APPEARED STRETCHED, EXPOSING THE CORE. NO PATIENT EFFECTS WERE REPORTED FROM THIS PROCEDURE; HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED A SEPARATION OF THE GUIDE WIRE CORE AND THE SHAPING RIBBON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX GUIDANT VASCULAR INTERVENTION NA 2011051

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 2. INFLATION DEVICE: GDT,| 1. DILATATION CATHETER: TERUMO HAYATE 2.0-20,| 3. GUIDING CATHETER: MDT ZUMA 2 6F.