BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2152624 · Received June 22, 2011

    Report

    Report Number
    3005168196-2011-00260
    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: THERE ARE KINKS IN THE PROXIMAL END OF THE SEPARATOR AT 7.0, 7.8 AND 8.7 CM FROM THE BEGINNING OF THE GREEN PFTE COATING. THERE IS ALSO A KINK IN THE DISTAL END, 8.6 CM FROM THE DISTAL TIP. THE SEPARATOR IS NOT BROKEN AS REPORTED. THE MAXIMUM WIDTH OF THE SEPARATOR BULB IS 0.02859" AND IS WITHIN SPECIFICATION. THE SEPARATOR IS NON-FUNCTIONAL. CONCLUSION: THE ORIGINAL COMPLAINT DESCRIBES TWO 032 SEPARATORS THAT FRACTURED DURING MANIPULATION THROUGH THE RHV. THE RETURNED SEPARATORS INCLUDED A SEPARATOR 032 AND SEPARATOR 026. THE SEPARATOR 032 WAS NOT BROKEN BUT KINKED IN THE REGION DESCRIBED IN THE COMPLAINT (AT THE PROXIMAL TAPER GRIND). THE SEPARATOR 026 WAS FRACTURED AS DESCRIBED IN THE COMPLAINT. BOTH KINKING AND BREAKING IN THIS REGION ARE FREQUENTLY SEEN WHEN THE PROXIMAL TAPER GRIND IS MANIPULATED OUTSIDE OF THE RHV DURING THE PROCEDURE. 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 3005168196-2011-00261 AND MDR 3005168196-2011-00262.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA, INC. F19434

    Patients

    Seq Age Sex Outcome Treatment
    1