BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3982151 · Received August 5, 2014

    Report

    Report Number
    3005168196-2014-00500
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PUSHER ASSEMBLY IS KINKED APPROXIMATELY 36.0, 63.0, 97.5 AND 103.0 CM FROM THE PROXIMAL END OF THE PUSHER WIRE. THE PET-LOCK IS STILL INTACT AND THE COIL IS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PROXIMAL END OF THE RUBY COIL IS COMPRESSED TOGETHER. THE STRETCH RESISTANT (SR) WIRE IS LOOPED AROUND THE DISTAL DETACHMENT TIP (DDT). CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE RUBY COIL WOULD NOT ADVANCE DISTALLY OUTSIDE THE COIL INTRODUCER SHEATH. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 36.0, 63.0, 97.5 AND 103.0 CM FROM THE PROXIMAL END.. THE PET-LOCK WAS STILL INTACT AND THE COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PROXIMAL END OF THE COIL WAS COMPRESSED TOGETHER. THE SR-WIRE WAS LOOPED AROUND THE (DDT). BASED ON THE EVENT DESCRIPTION AND THE EVALUATION OF THE DEVICE, IT APPEARS THAT THE FORCE USED TO ADVANCE THE RUBY COIL CAUSED THE PROXIMAL END OF THE COIL TO COMPRESS TOGETHER. THIS CAUSED THE OUTER DIAMETER OF THE RUBY COIL TO EXCEED PRODUCT SPECIFICATION INSIDE THE COIL INTRODUCER SHEATH, WHICH RESULTED IN THE COIL BEING STUCK INSIDE THE SHEATH. THE COILS INTRODUCER SHEATH WAS NOT DAMAGED. THE OUTER DIAMETER OF THE COIL AND (DDT) WERE MEASURED AND WERE WITHIN SPECIFICATION. THE INNER DIAMETER OF THE COIL INTRODUCER SHEATH WAS MEASURE AND WAS WITHIN SPECIFICATION; THEREFORE, IT'S NOT CLEAR AS WHAT CAUSED THE COIL TO GET STUCK IN THE INTRODUCER SHEATH. THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE RUBY COILS ARE 100% FUNCTIONAL TESTED DURING IN-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 AN EMBOLIZATION PROCEDURE USING RUBY COILS. THE TECHNICIAN FELT PRESSURE WHILE ADVANCING THE RUBY COIL THROUGH THE INTRODUCER SHEATH. THE PHYSICIAN DID NOT USE THE RUBY COIL IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457167 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F43215

    Patients

    Seq Age Sex Outcome Treatment
    1