BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGULIELMI DETACHABLE COIL

    MDR report key: 225131 · Received May 21, 1999

    Report

    Report Number
    6000078-1999-00044
    Event Type
    Malfunction
    Date Received
    May 21, 1999
    Date of Event
    March 29, 1999
    Report Date
    May 21, 1999
    Manufacturer
    TARGET THERAPEUTICS/ A DIV. OF BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TARGET WAS INFORMED THAT THE GDC COIL DID NOT DETACH WITH THE POWER SUPPLY, BUT DETACHED WHILE BEING RETRIEVED. THE PT WAS REPORTED IN GOOD CONDITION AFTER THE PROCEDURE. ADDITIONAL INFO HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGULIELMI DETACHABLE COIL Implant DETACHABLE COIL HCG TARGET THERAPEUTICS/ A DIV. OF BOSTON SCIENTIFIC CORP. NA A82794

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO EXPIRATION DATE-NI.| BRAND NAME-FAST TRACKER, TYPE OF DEVICE INFUSER| CATHETER, MODEL #-NI, CATALOG #-134XX SER#NI,