BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-SELECT NITINOL GUIDEWIRE

    MDR report key: 24132 · Received February 16, 1994

    Report

    Report Number
    2950672-1994-00001
    Event Type
    Injury
    Date Received
    February 16, 1994
    Date of Event
    January 13, 1994
    Report Date
    January 18, 1994
    Manufacturer
    MICROVENA CORPORATION
    Product Code
    MKI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PTCA PROCEDURE FOR CORONARY STENT PLACEMENT, THE COIL OF THTHE GUIDEWIRE WAS STRETCHED LIKE AN "ACORDION". UPON WITHDRAWAL OF THE GUIDEWIRE INTO THE GUILDING CATHETER, THE ENTIRE COIL SECTION OF THE GUIDEWIRE WAS COMPLETELY DETACHED FROM THE SHAFT. THE COIL COULD NOT BE RETRIEVED FROM THE LAD ARTERY. PT UNDEERWENT CABG ON 1/19/94 AT WHICH TIME, THE COIL WAS PARTIALLY RETREIVED (3CM OF COIL REMAINED IN RETRIEVED (3CM OF COIL REMAINED IN LAD). THE PT IS REPORTED TO BE IN GOOD CONDITION AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-SELECT NITINOL GUIDEWIRE PTCA GUIDEWIRE MKI MICROVENA CORPORATION NA 1625

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention USCI RINT 2.5MM PTCA BALLOON CATHETER