BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR FLEX 032

    MDR report key: 2021346 · Received February 8, 2011

    Report

    Report Number
    3005168196-2011-00025
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 10, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K100769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ADVANCING THE PENUMBRA SYSTEM SEPARATOR FLEX 032 AND NOTICED AN INCREASE IN FRICTION AND HAD TROUBLE ADVANCING THE SEPARATOR. THE PHYSICIAN REMOVED THE SEPARATOR FROM THE CATHETER AND NOTICED A KINK APPROX 10 INCHES FROM THE PROXIMAL END. THE PHYSICIAN REPLACED IT WITH ANOTHER SEPARATOR AND FINISHED THE CASE WITHOUT INCIDENT. THE PHYSICIAN DID NOT RECALL WHEN THE KINK OCCURRED AND HAD NOT NOTICED A KINK IN THE SEPARATOR PRIOR TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR FLEX 032 NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR