BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 SOFT 4MM X 8CM

    MDR report key: 4223198 · Received November 4, 2014

    Report

    Report Number
    3008853977-2014-00343
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE DISTAL TIP SNAPPED OFF. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705670 TARGET 360 SOFT 4MM X 8CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 17660041

    Patients

    Seq Age Sex Outcome Treatment
    1