BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1420004 · Received April 13, 2009

    Report

    Report Number
    3005168196-2009-00021
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    March 20, 2009
    Report Date
    April 13, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE, BUT HAS NOT YET BEEN RETURNED FROM THE HOSPITAL. MDR REPORTABILITY WILL BE DETERMINED AFTER DEVICE ANALYSIS.

    Description of Event or Problem · 1

    THE CLEAR PLASTIC HUB OF THE NEURON DELIVERY CATHETER 053 APPEARED TO CRACK DURING THE PROCEDURE. THE PHYSICIAN SAID HE PLACED HIS HAND ON THE HUB AND FELT A "POP". THE DELIVERY CATHETER 053 THEN LEAKED DURING INJECTIONS OF CONTRAST, WHICH APPEARED TO FLOW FROM THE UNION OF THE YELLOW STRAIN RELIEF AND THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14279

    Patients

    Seq Age Sex Outcome Treatment
    1