BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 SOFT 4MM X 15CM

    MDR report key: 24684410 · Received March 25, 2026

    Report

    Report Number
    3008881809-2026-00165
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 21, 2026
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    04546540676481
    PMA / PMN Number
    K242243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF THE SUBARACHNOID HEMORRHAGE (SAH), THE SUBJECT COIL PREMATURELY DETACHED DURING USE AND WAS PUSHED INTO THE COIL MASS BY THE COIL DELIVERY WIRE. 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
    469515 TARGET 360 SOFT 4MM X 15CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 24391942 04546540676481

    Patients

    Seq Age Sex Outcome Treatment
    1