BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 6965598 · Received October 20, 2017

    Report

    Report Number
    3008881809-2017-00446
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 20, 2017
    Report Date
    December 26, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. INFORMATION AVAILABLE INDICATED THAT, THE COIL WAS ADVANCED THROUGH A NON-STRYKER( PROWLER SELECT PLUS) MICROCATHETER, THE INTERNAL DIAMETER (ID) OF THIS MICROCATHETER IS 0.021. AS PER THE TARGET DFU, TARGET DETACHABLE COILS ARE COMPATIBLE WITH STRYKER NEUROVASCULAR 2-TIP MARKER MICROCATHETERS (MIN. INTERNAL DIAMETER 0.41 MM [0.016 IN], MAX. INTERNAL DIAMETER 0.48 MM [0.019 IN]). IT IS PROBABLE THAT THE LARGER ID OF THE MICROCATHETER USED CAUSED DAMAGE TO THE COILS DURING ADVANCEMENT, LEADING TO THE AS REPORTED PREMATURE DETACHMENT OF THE COIL. THEREFORE AN ASSIGNABLE CAUSE OF USER ERROR WILL BE ASSIGNED TO THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAIALBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE DETACHED COIL WAS PUSHED OUT OF CATHETER INTO THE PATIENT'S BODY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE DETACHED COIL WAS PUSHED OUT OF CATHETER INTO THE PATIENT'S BODY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745127 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1