BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-STANDARD SYNERG DETECTION CIRCUIT

    MDR report key: 461748 · Received May 19, 2003

    Report

    Report Number
    6000078-2003-00064
    Event Type
    Malfunction
    Date Received
    May 19, 2003
    Date of Event
    March 13, 2003
    Report Date
    May 19, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIVISION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED THAT THE GDC-4 10 REGULAR COIL WAS BROKEN INSIDE OF THE EXCELSIOR 1018 2-TIP MICRO-CATHETER. THE DEVICE WAS BEING USED TO TREAT A CAROTID CAVEMOUS FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-STANDARD SYNERG DETECTION CIRCUIT DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIVISION * 4477755

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO EXPIRATION DATE: 12/31/2004| BRAND NAME: 1. EXCELSIOR 1018 MICROCATHETER| CATALOG#: 144189,