BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA CATHETER 025 (PX400 MICROCATHETER)

    MDR report key: 2142155 · Received May 26, 2011

    Report

    Report Number
    3005168196-2011-00230
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER SHAFT WAS EXAMINED FOR DEFECTS. THERE WERE NO NOTICEABLE KINKS ON THE CATHETER SHAFT. A 0.025 IN STAINLESS STEEL MANDREL WAS PASSED THROUGH THE LUMEN WITHOUT DIFFICULTY. THE CATHETER IS FULLY FUNCTIONAL. CONCLUSION: THE CATHETER WAS RETURNED AS PART OF A COMPLAINT RELATED TO THE INABILITY TO DETACH COILS. THE CATHETER DID NOT CONTRIBUTE TO THE NOTED 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

    THE PHYSICIAN WAS ATTEMPTING TO COIL AN UNRUPTURED, RIGHT, 11 MM BASILAR ARTERY ANEURYSM IN A PATIENT WITH VERY TORTUOUS ANATOMY. THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE FIRST COIL USING A PENUMBRA COIL 400 DETACHMENT HANDLE, EACH TIME UNSUCCESSFULLY. THE PHYSICIAN WITHDREW THE COIL, AND ATTEMPTED TO PLACE ANOTHER COIL WITH A NEW DETACHMENT HANDLE. AFTER SEVERAL UNSUCCESSFUL TRIES WITH THE HANDLE, THE PHYSICIAN TRIED TO MANUALLY SEPARATE THE PULL WIRE BY HAND. THIS ATTEMPT ALSO FAILED TO DEPLOY THE COIL. THE PHYSICIAN COMMENTED THAT AS HE PULLED ON THE PULL WIRE HE FELT A STRETCHINESS IN THE WIRE AND A REFLUX BACK ON EACH PULL LIKE A RUBBER BAND. THE PHYSICIAN THEN DECIDED TO REMOVE THE COIL, WHICH RESULTED IN THE COIL DETACHING INSIDE THE PENUMBRA PX400 MICROCATHETER. HE THEN DECIDED TO PUSH THE COIL BACK INTO THE ANEURYSM WITH THE PUSHER. THE COIL WAS SUCCESSFULLY ABLE TO BE REDEPLOYED BACK INTO THE ANEURYSM. THE PHYSICIAN REMOVED THE PX400 AND USED ANOTHER PRODUCT TO COMPLETE THE COILING. THE PATIENT WAS ALERT AND INTACT AFTER THE PROCEDURE. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00228 THROUGH 3005168196-2011-00232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA CATHETER 025 (PX400 MICROCATHETER) DQY PENUMBRA INC. F19107

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR