BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3873058 · Received June 13, 2014

    Report

    Report Number
    3005168196-2014-00381
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLIANT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL WAS CATCHING ON THE EDGE OF THE PXSLIM CATHETER WHILE ADVANCING THE COIL OUT OF THE DISTAL TIP. IT ALSO STATES THAT THE COIL WAS ADVANCED AND RETRIEVED ON THE STERILE BENCH OUTSIDE THE PATIENT AND CATCHING CONTINUED. EVALUATION OF THE RETURNED DEVICE REVEALED A KINK IN THE PROXIMAL END OF THE PUSHER ASSEMBLY, LIKELY RELATED TO REPEATED ATTEMPTS TO PUSH THE COIL THROUGH THE CATHETER. IN ADDITION, THE DISTAL TIP OF THE PXSLIM MICROCATHETER IS OVALIZED. THE LIKELY CAUSE OF THE ORIGINAL COMPLAINT IS DEFORMATION (OVALIZATION) OF THE DISTAL TIP OF THE MICROCATHETER CAUSING THE LUMEN OF THE CATHETER TO BE INCOMPATIBLE WITH THE OUTER DIAMETER OF THE COIL WHICH FELT AS THOUGH IT WAS "CATCHING" ON THE CATHETER AS DESCRIBED IN THE COMPLAINT. IT WAS NOTED DURING EVALUATION THAT THE CATHETER TIP WAS STEAM SHAPED BY THE USER. THE TIP MAY HAVE BEEN DEFORMED DURING THIS PROCESS. THESE DEVICES ARE 100% INSPECTED FOR DAMAGE DURING PACKAGING.

    Additional Manufacturer Narrative · 1

    RESULT: THE COIL IS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WIRE IS SLIGHTLY KINKED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END OF THE WIRE. CONCLUSION: THE COMPLIANT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL WAS CATCHING ON THE EDGE OF THE PXSLIM CATHETER WHILE ADVANCING THE COIL OUT OF THE DISTAL TIP. IT ALSO STATES THAT THE COIL WAS ADVANCED AND RETRIEVED ON THE STERILE BENCH OUTSIDE THE PATIENT AND CATCHING CONTINUED. EVALUATION OF THE RETURNED DEVICE REVEALED A KINK IN THE PROXIMAL END OF THE PUSHER ASSEMBLY, LIKELY RELATED TO REPEATED ATTEMPTS TO PUSH THE COIL THROUGH THE CATHETER. IN ADDITION, THE DISTAL TIP OF THE PXSLIM MICROCATHETER IS OVALIZED. THE LIKELY CAUSE OF THE ORIGINAL COMPLAINT IS OVALIZATION OF THE DISTAL TIP OF THE MICROCATHETER CAUSING THE LUMEN OF THE CATHETER TO BE INCOMPATIBLE WITH THE OUTER DIAMETER OF THE COIL WHICH FELT AS THOUGH IT WAS "CATCHING" ON THE CATHETER AS DESCRIBED IN THE COMPLAINT. THESE DEVICES ARE 100% INSPECTED FOR DAMAGE DURING PACKAGING. THE OVALIZATION IN THE DISTAL TIP OF THE MICROCATHETER MAY HAVE BEEN RELATED TO HANDLING OF THE DEVICE DURING REMOVAL FROM THE PACKAGING AND PREPARATION FOR USE. 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 3005168196-2014-00382.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 AND A PX SLIM DELIVERY MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FELT THE DISTAL END OF THE COIL 400 SNAG THE TIP OF THE PX SLIM MICROCATHETER. THIS CAUSED THE CATHETER TIP TO DISLODGE FROM THE COIL MASS. THE PX SLIM AND COIL 400 WERE REMOVED AND THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350099 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F38900

    Patients

    Seq Age Sex Outcome Treatment
    1