BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 026

    MDR report key: 2013703 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00031
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    April 13, 2008
    Report Date
    April 15, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: VISUAL - THE PRODUCT WAS RETURNED WITHOUT KINKS OR OTHER DAMAGE OBSERVED. FUNCTIONAL - A 0.015" MANDREL PASSED THROUGH THE LUMEN. A 0.026" MANDREL PASSED THROUGH THE LUMEN. CONCLUSION: THE CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. THE CATHETER MET ALL DIMENSIONAL SPECIFICATIONS THAT WERE MEASURED. A POSSIBLE CAUSE COULD HAVE BEEN A SHARP BEND ON THE DISTAL END OF THE WIRE. THIS COULD CAUSE THE WIRE TO BEND BACK ON ITSELF AT THE TAPER. THIS THEORY COULD NOT BE INVESTIGATED AS THE WIRE WAS NOT RETURNED FOR EVAL. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    UPON REMOVING THE PSC 026 FROM THE PACKAGING, A CRACK WAS NOTICED AT THE HUB OF THE CATHETER. THE CATHETER WAS NEVER REMOVED FROM THE HOOP AND IS BEING RETURNED. THE PHYSICIAN HAD TROUBLE TRACKING THE SECOND CATHETER USED IN THE CASE OVER THE WIRE. AFTER REMOVING THE CATHETER AND WIRE FROM THE PT, IT WAS OBSERVED THAT THE WIRE DID NOT PASS THROUGH THE CATHETER. NO KINKS WERE OBSERVED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00153.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 026 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F12290

    Patients

    Seq Age Sex Outcome Treatment
    1