BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3841542 · Received May 30, 2014

    Report

    Report Number
    3005168196-2014-00353
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 2, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PET-BUMP ON THE DISTAL TIP OF THE PULL-WIRE WAS STILL IN THE CAPTURE FEATURE OF THE DISTAL DETACHMENT TIP (DDT) AND SHOWED NO DEFECTS UPON INSPECTION. THE PROXIMAL PET-LOCK WAS BROKEN ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY ALSO HAS A SHAPE IN THE HYPO-TUBE AREA PROXIMAL OF THE MID-SHAFT. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL WOULD NOT DETACH. EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE ISSUE DESCRIBED IN THE COMPLAINT. ONCE THE DEVICE WAS FULLY DECONTAMINATED, THE COIL DETACHED WITHOUT ISSUE. THE RETURNED DEVICE HAD A BROKEN PET LOCK AT THE PROXIMAL END OF THE PUSHER ASSEMBLY INDICATING THAT PROPER DETACHMENT USING THE DETACHMENT HANDLE WAS ATTEMPTED. IN ADDITION, THERE WAS NO ABNORMAL FRICTION NOTED BETWEEN THE PULL WIRE AND PUSHER ASSEMBLY AFTER DECONTAMINATION. THE DISTAL BUMP ON THE PULL-WIRE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. BASED ON THESE RESULTS AND THE DESCRIPTION OF THE EVENT, IT APPEARS THAT THE COIL WAS DIFFICULT TO DETACH DUE TO TORTUOUS PATIENT ANATOMY WHICH CAUSED A BUILD-UP OF FRICTION BETWEEN THE PUSHER ASSEMBLY AND PULL-WIRE. THE BEND IN THE PUSHER ASSEMBLY WAS LIKELY CAUSED DURING PACKAGING FOR RETURN. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. 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 FOR AN AORTIC ANEURYSM USING A RUBY COIL. DURING THE PROCEDURE, WHILE THE COIL WAS IN ANEURYSM, IT WOULD NOT DETACH. THE COIL WAS RETRACTED AND A DIFFERENT COIL WAS USED. THERE WAS NO REPORTED ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318385 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F40094

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR