BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET XL 360 STANDARD 12MM X 45CM

    MDR report key: 15259487 · Received August 19, 2022

    Report

    Report Number
    3008881809-2022-00402
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 20, 2022
    Report Date
    October 31, 2022
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    04546540711281
    PMA / PMN Number
    K153658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT AVAILABLE TO MANUFACTURER.

    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, FUNCTIONAL TESTING AS WELL AS VISUAL 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. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THE EVENT OF MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE PATIENT ANATOMY BY PUSHING INTO THE MAV IN ANOTHER FRAMING COIL. A NON-STRYKER MICROCATHETER WAS INTRODUCED. A SNARE DEVICE WAS USED AS MEDICAL INTERVENTION TO REMOVE THE SUBJECT COIL FROM PATIENT'S ANATOMY. THERE WAS FIFTEEN MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE PATIENT ANATOMY BY PUSHING INTO THE MAV IN ANOTHER FRAMING COIL. A NON-STRYKER MICROCATHETER WAS INTRODUCED. A SNARE DEVICE WAS USED AS MEDICAL INTERVENTION TO REMOVE THE SUBJECT COIL FROM PATIENT'S ANATOMY. THERE WAS FIFTEEN MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995304 TARGET XL 360 STANDARD 12MM X 45CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK M0036101240 23314434 04546540711281

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention DUO HEADWAY MICROCATHETER (NON-STRYKER).