BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XXL 360 8MM X 40CM

    MDR report key: 17872935 · Received October 4, 2023

    Report

    Report Number
    3008881809-2023-00491
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 4, 2023
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    07613327466423
    PMA / PMN Number
    K161429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL TESTING AS WELL AS FUNCTIONAL TESTING CANNOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. THE INFORMATION RECEIVED INDICATES THAT INTERMITTENT FLUSH WAS USED. IN ADDITION, A HEADWAY 21 MICROCATHETER WHICH HAS A LARGER ID (0.021") THAN RECOMMENDED BY THE DFU WAS USED IN THE PROCEDURE. PER THE DIRECTIONS FOR USE (DFU): "IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF THE TARGET DETACHABLE COIL SYSTEM AND TO REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT A CONTINUOUS INFUSION OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN A) THE FEMORAL SHEATH AND GUIDING CATHETER, B) THE 2-TIP MICROCATHETER AND GUIDING CATHETERS, AND C) THE 2-TIP MICROCATHETER AND STRYKER NEUROVASCULAR GUIDEWIRE AND DELIVERY WIRE. CONTINUOUS FLUSH ALSO REDUCES THE POTENTIAL FOR THROMBUS FORMATION ON, AND CRYSTALLIZATION OF INFUSATE AROUND, THE DETACHMENT ZONE OF THE TARGET DETACHABLE COIL". "TARGET XXL DETACHABLE COILS ARE COMPATIBLE WITH STRYKER NEUROVASCULAR 2-TIP MARKER MICROCATHETERS WITH A 0.48 MM [0.019 IN] INTERNAL DIAMETER". AN ASSIGNABLE CAUSE OF USE ERROR WILL BE ASSIGNED TO THE REPORTED COMPLAINT AS THE INVESTIGATION CONFIRMS THAT THERE WAS AN ACT OR OMISSION THAT RESULTED IN A DIFFERENT MEDICAL PRODUCT RESPONSE THAN INTENDED BY THE MANUFACTURER AND/OR EXPECTED BY THE USER. H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, WHEN THE SUBJECT COIL WAS ADVANCED THROUGH A NON STRYKER MICROCATHETER WITH INTERMITTENT FLUSH, THE RESISTANCE WAS TOO STRONG IN THE SHAFT TO BE ADVANCED. WHEN THE SUBJECT COIL WAS RETRIEVING FROM THE MICROCATHETER, IT GOT FRACTURED AT THE COIL JUNCTION WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104264 TARGET XXL 360 8MM X 40CM DEVICE, NEUROVASCULAR EMBOLIZATIONDEVICE HCG STRYKER NEUROVASCULAR CORK 23979347 07613327466423

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEADWAY 21 MICROCATHETER (NON STRYKER)