BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 4241775 · Received November 10, 2014

    Report

    Report Number
    3005168196-2014-00802
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    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.

    Additional Manufacturer Narrative · 1

    RESULT: THE PC400 COIL PUSHER ASSEMBLY WAS KINKED IN MULTIPLE LOCATIONS ALONG THE HYPO-TUBE. THE PUSHER ASSEMBLY WAS FRACTURED APPROXIMATELY 50.0 CM AND 56.0 CM FROM THE PROXIMAL END. THE PET LOCK WAS INTACT. THE COIL WAS DETACHED FROM THE PUSHER ASSEMBLY WITH THE PROXIMAL CONSTRAINT SPHERE INTACT. THE OUTER DIAMETER OF THE COIL, PROXIMAL CONSTRAINT SPHERE, PULL WIRE, AND DISTAL DETACHMENT TIP (DDT) WERE MEASURED WITHIN SPECIFICATION. THE INNER DIAMETER OF THE DDT WAS MEASURED WITHIN SPECIFICATION. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLIANT INDICATES THAT A KINK WAS FOUND IN THE PC400 COIL DELIVERY WIRE DURING THE INSERTION THROUGH A PXSLIM. THE COMPLAINT ALSO STATES THAT THE DELIVERY PUSHER WAS PULLED SLIGHTLY AND THE COIL WAS CONFIRMED DETACHED IN THE PXSLIM. EVALUATION OF THE RETURNED PRODUCT REVEALED MULTIPLE KINKS IN THE PUSHER ASSEMBLY. THESE KINKS APPEAR TO BE FROM THE PACKAGING OF THE PRODUCT TO BE RETURNED FOR EVALUATION AND WERE NOT MENTIONED IN THE COMPLAINT REPORT. THE PUSHER ASSEMBLY WAS FRACTURED IN TWO LOCATIONS IN THE PROXIMAL END OF THE HYPO-TUBE. THESE FRACTURES COULD BE ASSOCIATED WITH THE COIL DETACHING INSIDE THE PXSLIM; HOWEVER, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THESE DEVICES ARE 100% FUNCTIONAL TEST DURING PROCESS 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 A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY (BA) USING A PENUMBRA COIL 400. DURING THE PROCEDURE, WHILE ADVANCING THE THIRD PENUMBRA COIL 400, THE PHYSICIAN NOTICED THAT THE PUSHER ASSEMBLY OF THE COIL WAS KINKED. AS THE PHYSICIAN PULLED THE COIL, THE COIL UNINTENTIONALLY DETACHED INSIDE A PX SLIM DELIVERY MICROCATHETER. THE PX SLIM DELIVERY MICROCATHETER WAS REMOVED FROM THE PATIENT ALONG WITH THE DETACHED COIL. THE PX SLIM DELIVERY MICROCATHETER WAS FLUSHED WITH A SYRINGE TO REMOVE THE DETACHED COIL. THE PHYSICIAN CONTINUED THE PROCEDURE WITH THE SAME PX SLIM DELIVERY MICROCATHETER WITH A NEW PENUMBRA COIL 400. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723311 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F38860

    Patients

    Seq Age Sex Outcome Treatment
    1