BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER NEUROVASCULAR NEUROFORM ATLAS WITHOUT TIP

    MDR report key: 15242105 · Received August 16, 2022

    Report

    Report Number
    MW5111511
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Report Date
    August 12, 2022
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    NJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN PREPPING STENT TO GO IN PATIENT, UNABLE TO GET CATHETER TO ADVANCE DURING TESTING. DID NOT GO INTO PATIENT AT ALL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486995 STRYKER NEUROVASCULAR NEUROFORM ATLAS WITHOUT TIP INTRACRANIAL NEUROVASCULAR STENT NJE STRYKER NEUROVASCULAR 21458714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown