BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET COIL

    MDR report key: 2091782 · Received May 17, 2011

    Report

    Report Number
    2939204-2011-00271
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS STRETCHED AND THE PROXIMAL END OF THE DELIVERY WIRE WAS BENT. THE PROXIMAL CONTACT WAS MISSING FROM THE PROXIMAL END OF THE DELIVERY WIRE AND WAS NOT RETURNED FOR ANALYSIS. THERE WERE NO ANOMALIES NOTED AT THE MAIN JUNCTION. FORM TIP BALL WAS FOUND TO BE INTACT. FROM THE INFORMATION PROVIDED AND THE INVESTIGATION RESULTS THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DAMAGE NOTED TO THE MAIN COIL AND THE PUSHER WIRE WOULD SUGGEST THAT THE FORCE MAY HAVE BEEN APPLIED DURING THE PROCEDURE RESULTING PROXIMAL CONTACT BEING SEPARATED FROM THE DELIVERY WIRE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THE REPORTED EVENT, AS THE PROCEDURAL ISSUES ENCOUNTERED BY THE USER LIMITED THE PERFORMANCE OF THE PRODUCT. THE PROXIMAL CONTACT IS A COMPONENT OF THE DEVICE LOCATED AT THE PROXIMAL END OF THE PUSHER WIRE AND REMAINS OUTSIDE THE PATIENT AT ALL TIMES DURING THE PROCEDURE; THERE IS NO CONTACT WITH THE PATIENT. MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    AFTER WITHDRAWAL OF THE DEVICE, THE PHYSICIAN NOTED THAT THE DISTAL PART OF THE DELIVERY WIRE WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING OTHER COILS.

    Description of Event or Problem · 1

    AFTER WITHDRAWAL OF THE DEVICE, THE PHYSICIAN NOTED THAT THE DISTAL PART OF THE DELIVERY WIRE WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING OTHER COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035432060 0014214680

    Patients

    Seq Age Sex Outcome Treatment
    1