BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC)

    MDR report key: 2032269 · Received March 29, 2011

    Report

    Report Number
    2939204-2011-00162
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICIATION. INSPECTION OF THE RETURNED DEVICE NOTED THAT THE COIL HAD SEPARATED FROM THE PUSHER WIRE. THERE WAS A KINK ON THE PUSHER WIRE 25CM FROM THE PROXIMAL END. THE PUSHER WIRE DISTAL END WAS EXAMINED UNDER MAGNIFICATION AND IT WAS EVIDENT THAT THE COIL HAD SEPARATED FROM THE PUSHER WIRE IN CLOSE PROXIMITY TO THE MAIN JUNCTION. REMAINS OF THE POLYETHYLENE TETRAPHTHALATE (PET) THAT SECURES THE COIL TO THE PUSHER WIRE WAS PRESENT SO IT WAS CONCLUDED THAT FORCE HAD CAUSED THE COIL TO SEPARATE FROM THE PUSHER WIRE. BASED ON THE INVESTIGATION FINDINGS AND THE INFORMATION PROVIDED, IT IS MOST LIKELY THAT OPERATIONAL CONTEXT WAS THE CAUSE OF THE COIL SEPARATING FROM THE PUSHER WIRE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL HAD SEPARATED FROM THE PUSHER WIRE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC) DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0033434080 3541947

    Patients

    Seq Age Sex Outcome Treatment
    1