BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET HELICAL NANO 1MM X 2CM

    MDR report key: 6196244 · Received December 21, 2016

    Report

    Report Number
    3008881809-2016-00329
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    July 21, 2016
    Report Date
    December 21, 2016
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K113412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT COIL DELIVERY WIRE, PROXIMAL CONTACT AND MAIN COIL WERE KINKED. THE MAIN COIL WAS BROKEN AND STRETCHED OUT. THE MAIN COIL SUTURE WAS DAMAGED AS WELL. INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED COIL. THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. IT IS LIKELY THAT PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED AND OBSERVED DAMAGES LIMITING THE PERFORMANCE OF THE COIL DURING THE CLINICAL PROCEDURE. THEREFORE, AN ASSIGNABLE CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL WAS BROKEN/ FRACTURED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842752 TARGET HELICAL NANO 1MM X 2CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 17863264

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR 10 MICROCATHETER (STRYKER)