BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 026

    MDR report key: 2192700 · Received June 22, 2011

    Report

    Report Number
    3005168196-2011-00261
    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: THE SEPARATOR WAS RETURNED IN TWO PIECES, THE PROXIMAL SECTION AND THE DISTAL SECTION WHICH WAS LODGED IN THE CATHETER. THE PROXIMAL SECTION OF THE SEPARATOR IS BROKEN 4.6 CM FROM THE BEGINNING OF THE PTFE COATING. THE DISTAL SECTION OF THE SEPARATOR WAS LODGED IN THE CATHETER AND WAS REMOVED DURING EVALUATION. THIS SECTION SHOWS A HOOK AT THE BREAK POINT AND BENDS IN THE MOST PROXIMAL 8 CM. THE CATHETER SHOWS NO VISIBLE DAMAGE. THE MAXIMUM WIDTH OF THE SEPARATOR BULB IS 0.02309", AND IS WITHIN SPECIFICATION. THE SEPARATOR IS NON FUNCTIONAL. 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 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 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 3005168196-2011-00262.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 026 NRY PENUMBRA, INC. F17026

    Patients

    Seq Age Sex Outcome Treatment
    1