BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC)

    MDR report key: 133314 · Received November 13, 1997

    Report

    Report Number
    6000078-1997-00030
    Event Type
    Malfunction
    Date Received
    November 13, 1997
    Date of Event
    September 25, 1997
    Manufacturer
    TARGET THERAPEUTICS/A BOSTON SCIENTIFIC COMPANY
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: DATE OF PROCEDURE: 9/25/1997. ON PUSHER WIRE IT WAS OBSERVED THAT CORE WIRE WAS BENT IN A 45 DEGREE ANGLE PROXIMAL TO HYPO TUBE. THREE WINDINGS FROM MAIN COIL WERE STRETCHED, BENT PROXIMALLY OVER HYPO TUBE, AND THEN CORE WIRE BROKE. PROXIMAL END OF MAIN COIL WAS FOLDED BACK UPON ITSELF IN CATHETER'S DISTAL SHAFT, 6.5CM PROXIMAL TO DISTAL END. MOST PROBABLE CAUSE FOR THESE ANOMALIES COULD BE USE OF GDC-10 COIL WITH TRACKER-18 UNIBODY CATHETER. PER THE LABELING INSTRUCTIONS: * "PRECAUTION: ONLY GDC-18 COILS SHOULD BE DELIVERED THROUGH TRACKER/FASTRACKER-18 INFUSION CATHETER. ONLY GDC-10 COILS SHOULD BE DELIVERED THROUGH TRACKER/FASTRACKER-18 CATHETER, GDC-10 COIL COULD FOLD BACK UPON ITSELF RESULTING IN JAMMING, STRETCHING OR BREAKING."

    Description of Event or Problem · 1

    IT WAS REPORTED TO TARGET THAT WITH THE GDC NOT FULLY INSERTED INTO THE ANEURYSM, THE PHYSICIAN PULLED THE COIL BUT THE COIL DETACHED IN THE CATHETER. THERE WAS NO IMPACT TO THE PT AND PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC) Implant DETACHABLE COIL HCG TARGET THERAPEUTICS/A BOSTON SCIENTIFIC COMPANY 340XXX A53522

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO