BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2984046 · Received February 28, 2013

    Report

    Report Number
    3005168196-2013-00084
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR EVALUATION AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE ENTIRE DISTAL PORTION THIS CATHETER IS PINCHED/SMASHED APPROXIMATELY. THE DISTAL PORTION OF THIS CATHETER IS CURLED FROM THE PINCH/SMASH IN THE SHAFT. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE PHYSICIAN DESCRIBES THAT THE CATHETER WAS FOUND FLATTENED DURING DEVICE PREPARATION. DURING EVALUATION THIS CATHETER WAS RE-INSERTED INTO ITS ORIGINAL HOOP WITH NO PROBLEM. THE CAUSE OF THIS DAMAGE CANNOT BE DIRECTLY DETERMINED AND WAS NOT MENTIONED IN THE COMPLAINT. HOWEVER, THE NATURE OF THE DAMAGE APPEARS TO BE CONSISTENT WITH HANDLING DAMAGE DURING DEVICE REMOVAL FROM THE PACKAGE AND DEVICE PREPARATION. THE FLATTENING SUGGESTS THE CATHETER MAY HAVE BEEN WHIPPED DOWN AND PINCHED ALONG THE DISTAL SHAFT. 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

    THE CATHETER FOUND FLATTENED DURING THE DEVICE PREPARATION, WAS NOT ABLE TO USE AT FIRST PLACE. THEREFORE THE PHYSICIAN CHANGE TO ANOTHER 032 CATHETER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87894 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F25381

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR