BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 026

    MDR report key: 2152642 · Received June 22, 2011

    Report

    Report Number
    3005168196-2011-00262
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A 0.026" MANDREL WAS INTRODUCED INTO THE HUB OF THE CATHETER AND ADVANCED DISTALLY. NO OBSTRUCTIONS OR UNUSUAL FRICTION POINTS WERE OBSERVED. THE CATHETER IS FULLY FUNCTIONAL. CONCLUSION: THE CATHETER RETURNED WITH THE SEPARATOR 026 SHOWED NO EVIDENCE OF DAMAGE AND WAS NOT MENTIONED IN THE COMPLAINT. 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

    WHILE THE PHYSICIAN WAS USING THE PENUMBRA SYSTEM SEPARATOR 032, ADVANCING AND RETRACTING THROUGH THE RHV, THE SEPARATOR KINKED AND SUBSEQUENTLY FRACTURED. THE PHYSICIAN USED A SECOND SEPARATOR AND THE SAME THING HAPPENED. BOTH DISTALLY FRACTURED SEGMENTS WERE EASILY RETRIEVED AS THEY WERE STILL IN THE RHV. THE PATIENT'S CONDITION WAS NOT ALTERED AS A RESULT OF THESE EVENTS AND THE PHYSICIAN CONTINUED THE PROCEDURE WITH THE PATIENT HAVING A SUCCESSFUL REVASCULARIZATION OF THE VESSEL. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00260 AND MDR 3005168196-2011-00261.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 026 NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1