BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1841661 · Received September 22, 2010

    Report

    Report Number
    2939204-2010-00944
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 23, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. ONLY THE PUSHER WIRE WAS RECEIVED FOR ANALYSIS. PHYSICAL ANALYSIS OF THE PUSHER WIRE REVEALED A KINK AT 34 CM FROM THE PROXIMAL END. MICROSCOPIC EXAMINATION REVEALED THAT THE INNER COIL WAS STILL ATTACHED TO THE PUSHER WIRE. THERE WAS POLYETHYLENE (PET) COVERING THE WINDS OF THE INNER COIL, AND THE EDGE OF THE PET WAS ROUGH. ANALYSIS DID NOT REVEAL EVIDENCE OF MALFUNCTION IN THE DETACHMENT ZONE OF THE PUSHER WIRE. THE FINDINGS ON THE EDGE OF THE PET IS INDICATIVE THAT THE JUNCTION HAD BEEN BROKEN, INDICATING SOME FORCE HAD BEEN USED WHICH RESULTED IN THE MAIN COIL BEING PULLED AWAY FROM THE INNER COIL. THE PUSHER WIRE WAS ALSO KINKED, WHICH WOULD INDICATE THE USE OF FORCE. BASED ON DEVICE ANALYSIS, IT IS PROBABLE THAT OPERATIONAL FACTORS MAY HAVE BEEN ENCOUNTERED DURING THE PROCEDURE. THEREFORE A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN 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 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003490306SR0 12194709

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR MICROCATHETER SL-10 (BOSTON SCIENTIFIC)