BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3129769 · Received May 24, 2013

    Report

    Report Number
    3005168196-2013-00183
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 25, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    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 3005168196-2013-00184.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PUSHER ASSEMBLY IS BROKEN APPROXIMATELY 109.0 CM FROM THE DISTAL TIP. THE PULL WIRE IS EXPOSED AT THE END OF THE BREAK SITE. THE PROXIMAL PET LOCK IS STILL INTACT WHICH IS CONSISTENT WITH AN UNDETACHED COIL. THE COIL IS UNRAVELED AND THE STRETCH RESISTANT (SR) WIRE IS BROKEN . CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT DURING THE RETRIEVAL OF THE COIL TO REPOSITION IN ANATOMY THE COIL BECAME STUCK. THE PHYSICIAN BELIEVES THE COIL DETACHED DURING THE RETRIEVAL. IF THE COIL ENCOUNTERS RESISTANCE DURING MANIPULATION IN THE PATIENT, AND THE FORCE USED TO RETRIEVE THE COIL IS GREATER THAN THE TENSILE STRENGTH OF THE PRODUCT, THE SR WIRE MAY BREAK. THE CAUSE OF THE BROKEN PUSHER ASSEMBLY IS UNKNOWN AND WAS NOT DESCRIBED IN THE COMPLAINT. 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 3005168196-2013-00184.

    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
    232186 PENUMBRA COIL 400 HCG, KRD KRD PENUMBRA, INC. F30813

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR