BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET HELICAL ULTRA 2.5 MM X 4 CM

    MDR report key: 3864537 · Received June 10, 2014

    Report

    Report Number
    3008853977-2014-00178
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. INFORMATION AVAILABLE INDICATED THAT THE BREAK WAS OBSERVED AFTER UNPACKING. BASED ON THE INFORMATION AVAILABLE, IT IS POSSIBLE THAT THE REPORTED BREAK MAY HAVE OCCURRED AS THE DEVICE WAS UNPACKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNPACKING, THE COIL WAS OBSERVED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNPACKING, THE COIL WAS OBSERVED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339011 TARGET HELICAL ULTRA 2.5 MM X 4 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15520442

    Patients

    Seq Age Sex Outcome Treatment
    1