BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIR

    MDR report key: 448314 · Received March 11, 2003

    Report

    Report Number
    6000078-2003-00014
    Event Type
    Malfunction
    Date Received
    March 11, 2003
    Date of Event
    February 11, 2003
    Report Date
    March 11, 2003
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE GDC 10-ULTRA SOFT STRETCH RESISTANT COIL SYNERG DETECTION CIRCUIT FRACTURED. ANOTHER WAS USED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIR DETACHABLE COIL HCG TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP * 5212722

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO