BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3813124 · Received May 15, 2014

    Report

    Report Number
    3005168196-2014-00319
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 14, 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

    RESULT: THE DISTAL DETACHMENT TIP (DDT) AT THE DISTAL TIP OF THE PUSHER ASSEMBLY STILL CONTAINS THE COIL PROXIMAL CONSTRAINT BALL. THE PROXIMAL CONSTRAINT BALL HAS A PIECE OF BROKEN STRETCH RESISTANT (SR) WIRE STILL ATTACHED. THE PET-LOCK AT THE PROXIMAL END OF THE PUSHER ASSEMBLY IS STILL INTACT INDICATING THE COIL WAS NOT DETACHED MANUALLY OR WITH THE DETACHMENT HANDLE. THE COIL IS DETACHED FROM THE PUSHER ASSEMBLY. THE COIL SR-WIRE APPEARS TO BE BROKEN. THE COIL WAS ALSO STRETCHED WHILE BEING REMOVED FROM THE STERILE POUCH PRIOR TO EVALUATION. CONCLUSION: THE DEVICE WAS RETURNED FOR ANALYSIS AND HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE COIL DETACHED ITSELF IN THE MICROCATHETER. EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE COIL WAS NOT DETACHED PROPERLY. THE COIL PROXIMAL CONSTRAINT BALL WAS STILL INSIDE THE DDT AND THE COIL SR WIRE WAS BROKEN. THESE OBSERVATIONS INDICATE THAT THE COIL WAS MANIPULATED WITH A FORCE IN EXCESS OF THE TENSILE STRENGTH SPECIFICATION OF THE SR WIRE MATERIAL. THE CAUSE OF THE RESISTANCE WHICH MAY HAVE REQUIRED THE USER TO EXERT EXCESS FORCE ON THE SYSTEM IS UNKNOWN BASED ON THE DESCRIPTION OF THE EVENT AND THE DEVICE INVESTIGATION. 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 A RUBY COIL. DURING THE PROCEDURE, THE COIL WAS UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED ALONG WITH THE C2 DIAGNOSTIC CATHETER. THE CORRECT PENUMBRA MICROCATHETER WAS USED AND THE FOLLOWING COILS WERE DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290442 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F40089

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR