BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA PX 400 MICROCATHETER

    MDR report key: 3129773 · Received May 24, 2013

    Report

    Report Number
    3005168196-2013-00184
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 25, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE HAS BEEN RETURNED AND IS PENDING AN INVESTIGATION. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00183.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00183. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING TREATMENT FOR DURAL ARTERIOVENOUS FISTULA WITH PENUMBRA COIL 400. THE COIL WAS ADVANCED WITH PX400 MICROCATHETER FROM THE RIGHT FEMORAL VEIN TO THE LEFT SIGMOID SINUS THROUGH THE RIGHT JUGULAR VEIN, TO THE RIGHT SIGMOID SINUS AND FINALLY TO THE RIGHT SINUS TRANSVERSUS. THE COIL WAS THEN ADVANCED; HOWEVER, THE DISTAL TIP OF THE CATHETER WAS SPRUNG, SO THE COIL WAS BROUGHT BACK. THE PHYSICIAN REPLACED THE PX40045 MICROCATHETER WITH A PX400STR MICROCATHETER AND TRIED THE APPROACH AGAIN. DURING THIS PROCEDURE THE COIL COULD NOT MOVE. THE PHYSICIAN THEN BELIEVED THE COIL WAS DETACHED. HE ATTEMPTED TO PULL OUT THE REST OF THE COIL, ABOUT 20 CM, BUT COULD NOT BECAUSE THE COIL WAS STUCK INSIDE THE PX400STR MICROCATHETER. ONLY THE PUSHER CAME BACK, AND THE COIL REMAINED INSIDE THE GUIDE CATHETER. A RENEGADE MICROCATHETER AND SOUTENIR FOREIGN OBJECT REMOVAL DEVICE WERE INSERTED INTO THE GUIDE CATHETER. THE COIL WAS CAPTURED INSIDE THE GUIDE CATHETER, AND REMOVED FROM THE BODY. THE COIL WAS UNRAVELED WHEN REMOVED. THE OPERATION WAS THEN COMPLETED SUCCESSFULLY AFTER REMOVAL WITH NINE OTHER PENUMBRA COILS. PHYSICIAN'S COMMENT: THE EVENT WAS ATTRIBUTED TO THE FACT THAT SUCH A LONG COIL WAS PLACED INTO A TIGHT SPOT WHILE THE CATHETER WAS BEING PUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231498 PENUMBRA PX 400 MICROCATHETER DQY DQY PENUMBRA, INC. F29121

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR