BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 5281162 · Received December 9, 2015

    Report

    Report Number
    3005168196-2015-01245
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013190
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE RUBY COIL PUSHER ASSEMBLY; THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 5.0, 48.0, AND 50.5 CM FROM THE PROXIMAL END; THE COIL WAS DETACHED FROM THE PUSHER ASSEMBLY AND THE DISTAL DETACHMENT TIP (DDT) WAS FRACTURED OFF THE DISTAL TIP OF THE PUSHER ASSEMBLY. CONCLUSION: EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE PUSHER ASSEMBLIES TO THE THREE RUBY COILS WERE DAMAGED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICE IS FORCEFULLY ADVANCED AGAINST RESISTANCE, IT IS LIKELY THAT DAMAGE WILL OCCUR. FURTHER EVALUATION REVEALED THAT THE THIRD RUBY COIL'S STRETCH RESISTANT WIRE (SR WIRE) WAS FRACTURED AND THE THIRD RUBY COIL'S DISTAL DETACHMENT TIP (DDT) WAS FRACTURED OFF OF THE DISTAL END OF THE PUSHER ASSEMBLY. THIS TYPE OF DAMAGE LIKELY OCCURRED DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICE IS FORCEFULLY RETRACTED AGAINST RESISTANCE, IT IS LIKELY THAT DAMAGE WILL OCCUR. THE UNINTENTIONAL DETACHMENT REPORTED IN THE COMPLAINT LIKELY OCCURRED DUE TO THE FRACTURE OF THE DDT OFF OF THE PUSHER ASSEMBLY. THERE WAS NO VISIBLE DAMAGE TO THE PX SLIMS. THE RUBY COILS ARE 100% FUNCTIONALLY TESTED DURING IN-PROCESS INSPECTION. THE PX SLIMS ARE 100% VISUALLY INSPECTED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2015-01246, 2. 3005168196-2015-01247, 3. 3005168196-2015-01248, 4. 3005168196-2015-01249.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING TWO RUBY COILS (LOT #F63538) THROUGH A PX SLIM, BOTH RUBY COIL PUSHER ASSEMBLIES BECAME KINKED. THE PHYSICIAN REMOVED THE TWO RUBY COILS AND THE PX SLIM FROM THE PATIENT AND THEN SUCCESSFULLY DEPLOYED AND DETACHED SEVEN NEW RUBY COILS INTO THE ANEURYSM USING A NEW PX SLIM. NEXT, THE PHYSICIAN ATTEMPTED TO DELIVER A NEW RUBY COIL (LOT #F65516) INTO THE ANEURYSM; HOWEVER, THE RUBY COIL STOPPED ADVANCING THROUGH THE PX SLIM AND THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE REMOVING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM AND BECAME STRETCHED. THE PHYSICIAN REMOVED BOTH THE PX SLIM AND THE STRETCHED RUBY COIL FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809752 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F65516 00814548013190

    Patients

    Seq Age Sex Outcome Treatment
    1