BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3982149 · Received August 5, 2014

    Report

    Report Number
    3005168196-2014-00506
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE COIL IS DETACHED FROM THE PUSHER ASSEMBLY. THE COIL IS INTACT WITH SOME MINOR HANDLING DAMAGE TO THE COIL LOOPS. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE FIRST COIL WAS TOO LONG AND WAS REMOVED. UPON RETRACTION, THE PUSHER ASSEMBLY WAS DAMAGED AND COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE SECOND COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER UPON RETRACTION. THE THIRD COIL WAS KINKED WHEN ATTEMPTING TO PUSH THE LAST 1 CM OF THE COIL INTO THE VESSEL. EVALUATION OF THE RETURNED DEVICES CONFIRMED THE DESCRIPTION OF THE COMPLAINT. THERE WERE NO PRODUCT ISSUES NOTED DURING THE DEVICE INVESTIGATION. ALL UNITS WERE MEASURED AND DETERMINED TO BE WITHIN SPECIFICATION AND THERE WERE NO MANUFACTURING ISSUES FOUND. IT APPEARS THAT ALL THREE COIL ISSUES WERE RELATED TO HANDLING AND PATIENT ANATOMY. THE TWO KINKED PUSHER ASSEMBLIES WERE LIKELY DAMAGED WHEN PUSHING THE DEVICE AGAINST RESISTANCE OR WHEN REMOVING THE DEVICE FROM THE PATIENT. IF THE PUSHER ASSEMBLY IS MANIPULATED AT AN ANGLE, THE DEVICE CAN KINK. IN ADDITION, THE FIRST COIL WAS COMPRESSED DISTALLY, INDICATING SOME RESISTANCE DURING RETRACTION OF THE COIL. THE SECOND COIL ISSUE, UNINTENTIONAL DETACHMENT, APPEARS TO HAVE BEEN CAUSED BY FORCE IN EXCESS OF THE TENSILE STRENGTH OF THE COIL DDT MECHANISM PLACED ON THE COIL DURING RETRACTION, CAUSING THE COIL TO SLIP FROM THE DDT WITHOUT BREAKING AND DETACH. THE CAUSE OF RESISTANCE OR DIFFICULTY MANEUVERING THE COILS IN THE PATIENT COULD NOT BE DETERMINED FROM THE RETURNED DEVICE EVALUATION OR THE DESCRIPTION OF THE COMPLAINT. THE COILS ARE 100% FUNCTIONALLY TESTED DURING INSPECTION AND VISUALLY INSPECTED FOR DAMAGE DURING PROCESSING. 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 3005168196-2014-00505 AND 00507.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE FEEDING VESSELS TO THE AORTA USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WAS FOUND TO BE TOO LARGE AND UPON RETRACTION OF THE PUSHER WIRE IT BECAME KINKED. ANOTHER RUBY COIL WAS UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHILE ATTEMPTING TO RETRACT IT. THE MICROCATHETER HAD TO BE REMOVED IN ORDER TO RETRIEVE THE DETACHED RUBY COIL. A THIRD RUBY COIL PUSHER BECAME KINKED WHILE DEPLOYING COIL INTO THE ANEURYSM. THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457230 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F37094

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR