BEUDAMED
    FDA Adverse Event Other Summary report: N

    032 REPERFUSION CATHETER

    MDR report key: 1531004 · Received November 13, 2009

    Report

    Report Number
    3005168196-2009-00092
    Event Type
    Other
    Date Received
    November 13, 2009
    Date of Event
    October 13, 2009
    Report Date
    October 13, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THERE WAS A FLAT SPOT BETWEEN 20.8 AND 25.5CM FROM THE DISTAL TIP. THERE WERE MULTIPLE SINGLE AXIS BENDS BETWEEN 1.0 AND 6.0CM. IN ADDITION, TO FLAT SPOTS AT 10 AND 14CM FROM THE TIP. CONCLUSION: THIS WAS AN OFF-LABEL USE OF THE DEVICE (ASPIRATION OF A CLOT IN THE FEMORAL ARTERY). CONCLUSION: KINKED CATHETERS ARE REPORTABLE INCIDENTS PER FDA GUIDANCE AS OF (B)(4) 2009.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE 032 REPERFUSION CATHETER IN A LEG WITHOUT THE 032 REPERFUSION SEPARATOR. ASPIRATION WENT WELL BUT FLOW SUDDENLY STOPPED. THE PHYSICIAN THEN REMOVED THE REPERFUSION CATHETER AND NOTICED THAT IT WAS FLATTENED. THE PHYSICIAN THEN USED A NEW REPERFUSION CATHETER AND WAS ABLE TO FINISH ASPIRATING WITHOUT ANY PATIENT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 032 REPERFUSION CATHETER SUBCUTANEOUS CATHETER NRY PENUMBRA, INC. F15284

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization