BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 1080962 · Received July 23, 2008

    Report

    Report Number
    2029214-2008-00126
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SECTION OF THE CATHETER WAS RETURNED FOR EVAL WITH APPROXIMATELY 24 CM OF THE DISTAL SEGMENT MISSING. THE SEPARATION SITE HAS THE APPEARANCE OF EXPANDED CIRCUMFERENTIAL DILATATION CONSISTENT WITH BURSTS THAT MAY OCCUR DURING ANGIOGRAPHIC INJECTIONS. BASED ON THE INVESTIGATION, THE CATHETER APPEARS TO HAVE RUPTURED DURING ANGIOGRAPHIC INJECTION WHEN AN UNDETECTED KINK OR OTHER OBSTRUCTION OF THE CATHETER WAS PRESENT WHICH RESULTED IN PRESSURES EXCEEDING THE LIMITS OF THE CATHETER, AND THIS WAS NOT DETECTED UNTIL DELIVERY ONYX. THIS FAILURE MODE MAY SIGNIFICANTLY WEAKEN THE CATHETER MAKING IT PRONE TO EVENTUAL TENSILE SEPARATION DURING REMOVAL. CATHETER SEPARATION.

    Description of Event or Problem · 1

    DURING ONYX INJECTION, IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED IN THE CATHETER. ONYX WAS NOT SEEN EXITING OUT OF THE CATHETER TIP AND WAS OBSERVED AT THE BASILAR ARTERY. INJECTION WAS STOPPED. UPON CATHETER REMOVAL, THE CATHETER BROKE OFF AND APPROXIMATELY 15 CM OF THE BROKEN SEGMENT STAYED IN THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW-DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5065 4548399

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability