BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETERS

    MDR report key: 1760849 · Received July 14, 2010

    Report

    Report Number
    3005168196-2010-00528
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Report Date
    June 2, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG # 041, 054. THE PHYSICIAN DID NOT MAKE THE PENUMBRA TERRITORY MANAGER AWARE OF THIS PROBLEM AT THE TIME. ONLY AFTER HE RELOCATED THIS PRACTICE DID HE DISCUSS THE ISSUE CASUALLY AND AS AN ASIDE TO ANOTHER CONVERSATION WITH A PENUMBRA SALES REPRESENTATIVE. THE DEVICES WERE NOT RETURNED. WITHOUT THE RETURN OF THE DEVICES, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN EXPLAINED THAT HE HAS EXPERIENCED THE PENUMBRA SYSTEM REPERFUSION CATHETER COLLAPSE ALL ALONG THE BODY OF THE CATHETER. THIS MADE PASSING THE SEPARATOR WIRE THROUGH THE REPERFUSION CATHETER IMPOSSIBLE. WHEN THIS OCCURRED, THE REPERFUSION CATHETER WAS EXCHANGED FOR A NEW CATHETER AND THE CASE WAS COMPLETED SUCCESSFULLY. THE COLLAPSE OR NARROWING OF THE BODY OF SEVERAL DIFFERENT SIZES OF THE REPERFUSION CATHETER LINE HAS BEEN OBSERVED BY THE PHYSICIAN WHILE HE WAS AT A DIFFERENT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETERS PERCUTANEOUS CATHETER NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1