BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XXL 360 12MM X 45CM

    MDR report key: 21748610 · Received April 1, 2025

    Report

    Report Number
    3008881809-2025-00172
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 19, 2025
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    07613327128307
    PMA / PMN Number
    K242243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL AND FUNCTIONAL INSPECTIONS WERE NOT CONDUCTED DUE TO THE DEVICE WAS NOT RETURNED. 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. IT WAS REPORTED THAT DURING REPOSITIONING OF THE COIL, THE COIL WAS KINKED AND STRETCHED AND EVENTUALLY BROKE. 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, A CAUSE OF UNDETERMINABLE WAS ASSIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE MICROCATHETER KICKBACK OF THE SUBJECT COIL WAS OBSERVED. THE OPERATOR ATTEMPTED TO RIDE MICROCATHETER BACK OVER THE SUBJECT COIL TO REGAIN POSITION. HOWEVER, DURING THIS ATTEMPT THE SUBJECT COIL GOT KINKED AND STRETCHED. DELIVERY PUSHER WIRE (DPW WAS REMOVED AND THE SUBJECT COIL BROKE. FOUR SALINE INJECTIONS WERE USED TO PUSH THE SUBJECT COIL OUT OF THE CATHETER SUCCESSFULLY. THE SUBJECT DEVICE WAS REPLACED, AND 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 MICROCATHETER KICKBACK OF THE SUBJECT COIL WAS OBSERVED. THE OPERATOR ATTEMPTED TO RIDE MICROCATHETER BACK OVER THE SUBJECT COIL TO REGAIN POSITION. HOWEVER, DURING THIS ATTEMPT THE SUBJECT COIL GOT KINKED AND STRETCHED. DELIVERY PUSHER WIRE (DPW WAS REMOVED AND THE SUBJECT COIL BROKE. FOUR SALINE INJECTIONS WERE USED TO PUSH THE SUBJECT COIL OUT OF THE CATHETER SUCCESSFULLY. THE SUBJECT DEVICE WAS REPLACED, AND 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
    2698546 TARGET XXL 360 12MM X 45CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 24076866 07613327128307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EXCELSIOR 1018 CATHETER (STRYKER).