BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4152935 · Received October 8, 2014

    Report

    Report Number
    3005168196-2014-00700
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: BOTH RUBY COILS WERE STILL ATTACHED TO THE PUSHER ASSEMBLY AND THE PET-LOCKS WERE INTACT. THE PUSHER ASSEMBLY OF ONE OF THE TWO RUBY COILS WAS KINKED APPROXIMATELY 10.0 AND 14.0 CM FROM THE PROXIMAL END. THE RUBY COIL WAS NONFUNCTIONAL DUE TO DAMAGE TO THE PUSHER ASSEMBLY. THE OUTER DIAMETER OF BOTH RUBY COILS AND THE DISTAL DETACHMENT TIP (DDT) WERE MEASURED AND DETERMINED TO BE WITHIN SPECIFICATION. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE RUBY COILS EXPERIENCED RESISTANCE AND WOULD NOT ADVANCE DISTALLY TO THE END OF A PROGREAT MICROCATHETER (A NON-PENUMBRA DEVICE). EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE DIMENSIONS OF THE RETURNED DEVICES WERE WITHIN SPECIFICATION. THE COMPLAINT STATED THAT THE CATHETER USED TO ADVANCE THE COILS WAS DIMENSIONALLY COMPATIBLE WITH THE COIL SIZE THEREFORE; THE DEVICES SHOULD HAVE BEEN COMPATIBLE DURING USE. IT APPEARS THAT THE ISSUE DESCRIBED BY THE PHYSICIAN WAS NOT RELATED TO THE DEVICES BUT POSSIBLY RELATED TO PATIENT ANATOMY. HOWEVER, THE PROGREAT MICROCATHETER (NON-PENUMBRA DEVICE) WAS NOT RETURNED THEREFORE, ITS DIMENSIONAL COMPATIBILITY WITH THE RETURNED COILS COULD NOT BE EVALUATED. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED FROM THE DESCRIPTION OF THE EVENT OR THE EVALUATION OF THE RETURNED DEVICES. THE KINK IN THE PUSHER ASSEMBLY OF THE RUBY COIL WAS LIKELY RELATED TO ATTEMPTS TO PUSH THE COIL THROUGH THE CATHETER AGAINST RESISTANCE AS DESCRIBED IN THE COMPLAINT. 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 3005168196-2014-00699.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH ANOTHER MANUFACTURER'S MICROCATHETER. THE RUBY COILS WERE NOT USED AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S PUSHABLE COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632046 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F41966

    Patients

    Seq Age Sex Outcome Treatment
    1