BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGLIELMI DETACHABLE COIL POWER SUPPLY

    MDR report key: 227388 · Received June 9, 1999

    Report

    Report Number
    6000078-1999-00059
    Event Type
    Malfunction
    Date Received
    June 9, 1999
    Date of Event
    March 25, 1999
    Report Date
    June 9, 1999
    Manufacturer
    TARGET THERAPEUTICS / A DIV. OF BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER A FOLLOW-UP BY A CO REP ON 6/10/1999: "A TRACKER EXCEL-14 WAS USED TO DELIVER THE FIRS COIL. THE BLEEDING OF THE PT WAS NOT CAUSED BY THE REMOVAL OF THE COIL. THERE WERE NO COMPLICATIONS NOR ADDITIONAL INTERVENTIONS FOR THE PT WHO IS OK AT HOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL POWER SUPPLY Implant GDC POWER SUPPLY HCG TARGET THERAPEUTICS / A DIV. OF BOSTON SCIENTIFIC CORP. NA 5439

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO CATALOG#: 451005-2.| DEVICE: INFUSION CATHETER, CATALOG #: 142609.| BRAND NAME GUGLIELMI DETACHABLE COIL-GDC, TYPE OF| BRAND NAME: 3.- GDC POWER SUPPLY, POWER SUPPLY.| BRAND NAME: 2.- TRACKER EXCEL-14 CATHETER, TYPE OF| DEVICE DETACHABLE COIL, CATALOG 340820 LOT A22752.