BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 1571474 · Received November 2, 2009

    Report

    Report Number
    3005168196-2009-00097
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 2, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THERE WAS A SINGLE AXIS BEND 0.6CM FROM THE DISTAL TIP. IN ADDITION, THERE WAS A SLIGHT OVALIZATION 6.0CM FROM THE TIP. RESULTS: THE INCIDENT WAS CONFIRMED AS REPORTED. IT SHOULD BE NOTED THAT THIS IS NOT THE USUAL OUT-OF-BOX (OOB) FAILURE MODE. MOST OOB FAILURES ON THIS PRODUCT SHOW FLATTENING OR OVALIZATION, WHILE THIS IS AN EXAMPLE OF A SINGLE-AXIS BEND. MOST OOB FAILURES ARE RETURNED IN THEIR ORIGINAL PACKAGING. THIS UNIT WAS DOUBLE BAGGED WITH BIOHAZARD LABELING. THE INCIDENT REPORT STATED THAT THE KINKED 070 NEURON WAS DISCOVERED DURING UNPACKING, BUT IT IS UNCLEAR WHETHER OR NOT THIS UNIT HAD PT CONTACT. CONCLUSION: AS PER FDA GUIDANCE ON 28 AUG 2009, KINKS (INCLUDING OOB) ARE REPORTABLE INCIDENTS. A DHR OF THIS MFG LOT HAS BEEN REVIEWED.

    Description of Event or Problem · 1

    UPON UNPACKING THE 070 NEURON, IT WAS NOTICED THAT THE NEURON HAD A KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15298

    Patients

    Seq Age Sex Outcome Treatment
    1