BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA 5MAX REPERFUSION CATHETER

    MDR report key: 3171270 · Received June 14, 2013

    Report

    Report Number
    3005168196-2013-00236
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE HAS BEEN RETURNED, BUT THE INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THERE IS DAMAGE IN THE DISTAL PORTION OF THE CATHETER. THERE ARE KINKS IN THE SHAFT APPROXIMATELY 9.0 CM, 10.5 CM, AND 12.5 CM FROM THE DISTAL TIP. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT INDICATES THAT THE CATHETER WAS FOUND DAMAGED OUT OF THE PACKAGE. DURING EVALUATION IT WAS NOTED THAT THERE WAS VISUAL DAMAGE IN THE DISTAL PORTION OF THE SHAFT. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED ALTHOUGH IMPROPER HANDLING OF THE DEVICE WHEN UNPACKING CAN CAUSE DAMAGE TO THE FLEXIBLE TIP. 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

    PENUMBRA 5MAX REPERFUSION CATHETER WAS IN USE BY PHYSICIAN AND HE COULD NOT GET A GUIDE WIRE TO PASS THRU IT. INSPECTION OF THE CATHETER REVEALED TWO FLATTENED AREAS NEAR THE DISTAL TIP. ANOTHER 5MAX CATHETER WAS PULLED OFF THE SHELF AND USED WITH NO ADVERSE EFFECTS ON THE PATIENT.

    Description of Event or Problem · 1

    5MAX REPERFUSION CATHETER WAS FOUND TO BE DAMAGED UPON REMOVAL FROM PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271741 PENUMBRA 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F32655

    Patients

    Seq Age Sex Outcome Treatment
    1