BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA REPERFUSION CATHETER 032

    MDR report key: 1830858 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00248
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    November 12, 2008
    Report Date
    November 20, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE DEVICE MAIN SHAFT WAS SEPARATED 30CM FROM THE HUB AND THE COIL WIRE WAS BROKEN. INSPECTION UNDER A MICROSCOPE SHOWED THAT THE DEVICE WAS BENT AT THE LOCATION OF THE SEPARATION PRIOR TO BREAKING. CONCLUSION: THE DEVICE MAY HAVE BEEN KINKED DURING REMOVAL FROM PACKAGING AND WASNT NOTICED UNTIL AFTER THE PHYSICIAN LOADED IT ON THE WIRE. ADDITIONAL MANIPULATION DURING DEVICE PREPARATION MAY HAVE CAUSED THE DEVICE TO SEPARATE. THE DHR FOR THIS MFG 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 # L12435). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L12435) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS POST HUB MOLDING AND (B)(4) VISUAL REJECTS POST COATING. (B)(4). THE LOT WAS RELEASED TO FINISHED GOODS AND A SCAR WAS ISSUED TO THE SUPPLIER. 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

    WHILE PREPARING FOR THE PROCEDURE, THE CATHETER WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA REPERFUSION CATHETER 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F12435

    Patients

    Seq Age Sex Outcome Treatment
    1