BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 2984043 · Received February 28, 2013

    Report

    Report Number
    3005168196-2013-00083
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 10, 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 RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THIS CATHETER IS KINKED APPROXIMATELY (6.7 CM) FROM THE HUB AT THE DISTAL END OF THE SPIRAL-CUT STRAIN RELIEF. THE CATHETER ALSO HAS PINCHES ALONG THE ENTIRE SHAFT. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT DESCRIPTION STATES THAT THE METAL COVER [STRAIN RELIEF] WAS FOUND KINKED DURING THE PROCEDURE. THIS DAMAGE COULD HAVE COME FROM MISHANDLING THE PRODUCT WHEN PLACING AND DURING MANIPULATION IN THE PATIENT. THIS CATHETER ALSO HAD PINCHES ALONG THE SHAFT. THE CAUSE OF THIS DAMAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CATHETER METAL COVER END WAS FOUND KINKED. IT WAS FOUND DURING THE OPERATION. RIGHT BEFORE ACCESS TO THE TARGET LESION, THE CATHETER DID NOT ADVENCE PROPERLY THEREFORE THE PHYSICIAN WITHDREW CATHETER AND FOUND THAT THE CATHATER WAS KINKED ON THE PROXIMAL END. NO OTHER DEVICES WERE USED. NO TORTUOUS VESSELS WERE FOUND. OTHER CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87893 PENUMBRA SYSTEM REPERFUSION CATHETER 041 NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR