BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 026

    MDR report key: 1833925 · Received September 13, 2010

    Report

    Report Number
    3005168196-2010-00607
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 18, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE CATHETER HAS A SINGLE AXIS BEND IN THE HYPOTUBE DISTAL TO THE HUB. A 0.026" MANDREL WAS INTRODUCED INTO THE HUB AND STOPPED IMMEDIATELY BEFORE THE KINK. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DAMAGE SEEN AGREES WITH THE DAMAGE REPORTED. THIS SORT OF DAMAGE COULD BE CAUSED BY ROUGH HANDLING DURING TRANSPORT OR HANDLING WHEN UNPACKING THE DEVICE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    TWO 026 REPERFUSION CATHETERS WERE OPENED AND UPON EXAMINATION OF BOTH CATHETERS, IT WAS DETERMINED THAT THERE WERE KINKS IN THE CATHETERS DISTAL TO THE HUB, IN THE AREA OF THE BLACK STRAIN RELIEF, RENDERING THE CATHETERS UNUSABLE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00608.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 026 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F16978

    Patients

    Seq Age Sex Outcome Treatment
    1