BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PX SLIM DELIVERY MICROCATHETER

    MDR report key: 3971909 · Received July 31, 2014

    Report

    Report Number
    3005168196-2014-00496
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00497 AND 00498.

    Additional Manufacturer Narrative · 1

    RESULT: THE PXSLIM MICROCATHETER HAD NO VISIBLE DAMAGE. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE ANGIOGRAPHIC CATHETER (NON-PENUMBRA) WAS PLACED AT THE ORIGIN OF INTERNAL ILIAC ARTERY. THE PXSLIM MICROCATHETER WAS ADVANCED ALONG ANOTHER (NON-PENUMBRA) CATHETER AND DEPLOYED WITH THE DISTAL PXSLIM MICROCATHETER, ABOUT 2.0 CM OUT OF THE ANGIOGRAPHIC CATHETER. A CONTINUOUS FLUSHING WAS NOT PERFORMED. THE COIL WAS INSERTED IN THE ARTERY WITHOUT AN INCIDENT. THE COIL WAS PULLED BACK INTO THE CATHETER TO CHANGE ITS SHAPE. DURING THE ATTEMPT TO RE-DEPLOY, THE COIL COULD NOT BE PUSHED FROM THE CATHETER. THE COIL WAS RETRIEVED, FLUSHED, AND RE-INSERTED; HOWEVER, THE COIL COULD NOT BE PLACED IN THE SAME LOCATION. ANOTHER COIL WAS RE-INSERTED AND ALSO STOPPED AND THE SAME POINT. THE COIL AND MICROCATHETER WERE REMOVED AND NO DAMAGE WAS OBSERVED. THE COMPLAINT ALSO STATES THAT THERE WAS A 'CATCHING FEELING' WHILE PULLING THE COIL INTO THE MICROCATHETER. THE COIL BROKE AND COULD NOT ADVANCE FORWARD. EVALUATION OF THE RETURNED DEVICES REVEALED NO DAMAGE TO THE PXSLIM MICROCATHETER. IN ADDITION, THE RETURNED 5F GUIDE CATHETER WAS VISUALLY INSPECTED AND NO DAMAGE WAS NOTED. THE FIRST COIL EVALUATED WAS STILL ATTACHED TO THE PUSHER ASSEMBLY AND WAS NOT BROKEN. HOWEVER, THE PROXIMAL END OF THE COIL INTRODUCER SHEATH WAS ADVANCED TOO FAR DISTALLY WHEN THE PHYSICIAN RE-SHEATHED THE COIL. THE PROXIMAL END OF THE SHEATH IS APPROXIMATELY 0.5 CM PROXIMAL TO THE DISTAL DETACHMENT TIP (DDT). THIS MAY HAVE DAMAGED THE COIL AND MADE IT DIFFICULT TO ADVANCE DURING THE RE-INSERTION. THE COIL APPEARS TO HAVE MULTIPLE KINKS ALONG ITS LENGTH INSIDE THE SHEATH. THE SECOND COIL EVALUATED WAS DETACHED FROM THE PUSHER ASSEMBLY DUE TO A FRACTURE IN THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE ENTIRE PULL WIRE WAS EXPOSED OUT OF THE FRACTURED DISTAL END OF THE PUSHER ASSEMBLY. THE PUSHER WIRE WAS KINKED APPROXIMATELY 9.5 CM FROM THE PROXIMAL END. THERE WAS NO DAMAGE TO THE PX SLIM MICROCATHETER OR THE 5F GUIDE CATHETER USED IN THIS COMPLAINT. THE ANGLE ON THE DISTAL TIP OF THE GUIDE CATHETER AND THE TORTUOSITY OF THE VESSELS COULD HAVE CONTRIBUTED TO THE DIFFICULTIES ADVANCING OF THE COIL. THE COIL ARE 100% FUNCTIONAL TESTED DURING INSPECTION. THE CATHETERS ARE 100% VISUALLY INSPECTED DURING INSPECTION. 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 PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE INNER ILIAC ARTERY USING THE PENUMBRA COIL 400 SYSTEM. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PX SLIM DELIVERY MICROCATHETER TWO CENTIMETERS OUT OF THE ANGIOGRAPHIC CATHETER WITHOUT CONTINUOUS FLUSHING. THE PHYSICIAN WAS ABLE TO ADVANCE A COIL AND DEPLOY IT IN THE TARGET VESSEL; HOWEVER, THE PHYSICIAN RETRACTED THE COIL BACK INTO THE CATHETER TO CHANGE ITS SHAPE. WHILE THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL AGAIN, IT BECAME STUCK AND WOULD NOT ADVANCE. THE COIL WAS REMOVED FROM THE PATIENT, WASHED WITH SALINE, AND ATTEMPTED TO DEPLOY AGAIN. THE COIL WOULD NOT ADVANCE ANY FURTHER THAN BEFORE. THE PHYSICIAN THEN USED A NEW PENUMBRA COIL 400, AND IT BECAME STUCK AT THE SAME POINT IN THE PX SLIM DELIVERY MICROCATHETER. THE PHYSICIAN THEN REMOVED THE PX SLIM DELIVERY MICROCATHETER AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW PX SLIM DELIVERY MICROCATHETER AND FOUR NEW PENUMBRA COILS. THERE WAS NO KINK IN THE CATHETER NOTED. THERE WAS REPORT OF AN ADVERSE EFFECT ON THE PATIENT. THE PHYSICIAN COMMENTED THAT HE EXPERIENCED A "CATCHING FEELING" WHEN PULLING THE COIL BACK INTO THE MICROCATHETER. THE PHYSICIAN ALSO MENTIONED THAT THE COIL BROKE AND THEN WOULD NOT ADVANCE FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446958 PX SLIM DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F41853

    Patients

    Seq Age Sex Outcome Treatment
    1