BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET HELICAL ULTRA 3 MM X 8 CM

    MDR report key: 3873097 · Received June 13, 2014

    Report

    Report Number
    3008853977-2014-00185
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 19, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AND MICROSCOPIC ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL HAD BROKEN FROM THE DELIVERY WIRE AT THE MAIN JUNCTION. THE DELIVERY WIRE AND PROXIMAL CONTACT WERE ALSO NOTED TO BE KINKED. FUNCTIONAL ANALYSIS WAS UNABLE TO BE PERFORMED. INFORMATION AVAILABLE INDICATED THAT NO ANOMALIES WERE IDENTIFIED ON THE DEVICE PRIOR TO USE AND THAT THE PHYSICIAN RETRACTED AND RE-INSERTED THE COIL SEVERAL TIMES DURING PROCEDURE. BASED ON THE INFORMATION AVAILABLE AND THE PRODUCT ANALYSIS THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO HANDLING OF THE DEVICE DURING USE.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE RETURNED DEVICE, IT WAS NOTED THAT THE MAIN COIL WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE RETURNED DEVICE, IT WAS NOTED THAT THE MAIN COIL WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350000 TARGET HELICAL ULTRA 3 MM X 8 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 17320049

    Patients

    Seq Age Sex Outcome Treatment
    1