BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XXL 360 24MM X 50CM

    MDR report key: 7315293 · Received March 5, 2018

    Report

    Report Number
    3008881809-2018-00097
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    December 12, 2017
    Report Date
    March 5, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K161429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL WAS BROKEN, STRETCHED AND JAMMED IN A NON-STRYKER MICROCATHETER. DUE TO THE DAMAGE NOTED TO THE MAIN COIL, FURTHER DIMENSIONAL INSPECTION COULD NOT BE PERFORMED. AS PER THE ADDITIONAL INFORMATION, THE COIL WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE AND THE COIL PREPARED AS PER DFU. IT WAS CONFIRMED THAT THE 0.021 MANDREL PASSED THROUGH THE RETURNED NON-STRYKER MICROCATHETER WITHOUT DIFFICULTY. AS PER THE TARGET XXL DFU "TARGET XXL DETACHABLE COILS ARE COMPATIBLE WITH STRYKER NEUROVASCULAR 2-TIP MARKER MICROCATHETERS WITH A 0.48 MM [0.019 IN] INTERNAL DIAMETER." IT IS LIKELY THAT THE MICROCATHETER WAS INCOMPATIBLE WITH THE TARGET COIL CAUSING THE AS REPORTED "DIFFICULTY INSERTING" AND "FAILURE TO DETACH". IT WAS NOTED THAT THE MICROCATHETER WAS FLATTENED TOWARDS THE DISTAL END WHICH MAY HAVE CONTRIBUTED TO THE AS REPORTED EVENT AS WELL. AN ASSIGNABLE CAUSE OF USE ERROR WILL BE ASSIGNED TO THE REPORTED ¿MAIL COIL DIFFICULTY INSERTING' AND 'MAIN COIL FAILED/UNABLE TO DETACH' AND THE ANALYZED 'MAIN COIL BROKEN/ FRACTURED¿, ¿MAIN COIL STRETCHED¿, AND ¿MAIN COIL JAMMED¿. AS THE INVESTIGATION CONFIRMS THAT THERE WAS AN ACT OR OMISSION OF AN ACT THAT RESULTED IN A DIFFERENT MEDICAL PRODUCT RESPONSE THAN INTENDED BY THE MANUFACTURER AND/OR EXPECTED BY THE USER.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157564 TARGET XXL 360 24MM X 50CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 19790707

    Patients

    Seq Age Sex Outcome Treatment
    1