BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA REPERFUSION CATHETER 032

    MDR report key: 1830784 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00221
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    September 11, 2008
    Report Date
    September 15, 2008
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THERE WERE SHARP KINKS AND FLAT SPOTS IN THE CATHETERS. CONCLUSION: BOTH DEVICES WERE KINKED WHEN ATTEMPTING TO REMOVE THEM FROM THEIR PACKAGING HOOPS. IF THE DEVICE IS PULLED IN ONE FULL MOTION, IT MAY GET STUCK TO THE HOOP OPENING CAUSING THE KINK. THIS EVENT OCCURS WHEN THE DEVICE AND THE HOOP OPENING ARE NOT LINEAR OR IF THE LOOP OPENING IS HELD AT AN ANGLE WHEN THE DEVICE IS REMOVED. THIS SAME FAILURE MODE WAS DUPLICATED USING 032 CATHETERS AND THE SAME KINKS WERE PRODUCED. THIS TYPE OF FAILURE HAS ALSO BEEN SEEN IN PREVIOUS INCIDENTS WHERE THE INCIDENT WAS NOT FLUSHED ENOUGH UPON REMOVAL, CAUSING THE DEVICE TO FLATTEN AT THE TIP. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #0854 (LOT # L12691). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L12691) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS POST HUB MOLDING AND (B)(4) VISUAL REJECTS POST COATING. THE LOT HAS PASSED ALL DIMENSIONAL MEASUREMENTS PER SPECIFICATION, IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE CATHETERS WERE GETTING STUCK ON THE PACKAGING MATERIAL AND KINKING WHEN TAKING THEM OUT OF THE PACKAGING HOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA REPERFUSION CATHETER 032 PERCUTANEOUS CATHETER NRY PENUMBRA INC. F12691

    Patients

    Seq Age Sex Outcome Treatment
    1