BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    MDR report key: 1990664 · Received February 15, 2011

    Report

    Report Number
    2939204-2011-00039
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 5, 2010
    Report Date
    January 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. VISUAL INSPECTION IDENTIFIED SMALL BLOOD MATTER IN THE DISTAL END OF THE INTRODUCER SHEATH SUGGESTIVE THAT INSUFFICIENT FLUSH HAD BEEN MAINTAINED. HOWEVER, THERE WAS ONLY A SMALL AMOUNT OF BLOOD AND THIS COULD HAVE BEEN DUE TO BACK FLOW DURING REMOVAL OF THE DEVICE. THE PROXIMAL END OF THE MAIN COIL WAS PROTRUDING FROM THE PROXIMAL END OF THE INTRODUCER SHEATH. THE PUSHER WIRE WAS KINKED 9CM FROM THE DISTAL END. THE PROXIMAL END THE COIL WAS EXTENSIVELY STRETCHED AND THE MID TO DISTAL END WAS KINKED. MICROSCOPE ANALYSIS OF THE COIL REVEALED THAT THE PET JUNCTION WAS BROKEN. THE INNER COIL WAS STILL PRESENT ON THE DISTAL END OF THE PUSHER WIRE INDICATING THAT THE COIL HAD NOT DETACHED BY ELECTROLYSIS AS THE DETACHMENT ZONE IS INTACT. IT IS LIKELY THAT THE COIL STRETCHED AS IT WAS ATTEMPTED TO WITHDRAW THE DEVICE AND IT IS PROBABLE THAT THE DEVICE BROKE AT THE PET JUNCTION DUE TO EXCESSIVE FORCE APPLIED TO THE DEVICE IN THE ATTEMPT TO REMOVE IT. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT WILL BE ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE ANALYSIS FOUND THAT THE POLYETHYLENE (PET) JUNCTION WAS BROKEN. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0033461030SR0 12560079

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR