BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4760259 · Received May 8, 2015

    Report

    Report Number
    3005168196-2015-00444
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    March 24, 2015
    Report Date
    April 3, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE SECOND RUBY COIL PET LOCK WAS INTACT. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 5.0, 18.0, 68.0, 77.0, 105.0, AND 112.0 CM FROM THE PROXIMAL END. THE COIL WAS STILL ATTACHED TO THE DDT, AND DAMAGED THROUGHOUT ITS LENGTH. THE COIL WAS SUCCESSFULLY DETACHED BY THE PENUMBRA INVESTIGATOR. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE INITIAL COMPLAINT INDICATED THAT THERE WERE ISSUES DETACHING THE RUBY COILS. EVALUATION OF THE RETURNED DEVICES REVEALED THAT ALL THREE RUBY COIL PUSHER ASSEMBLIES WERE KINKED. THIS TYPE OF DAMAGED TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING PREPARATION OR USE. IF THESE DEVICES ARE MANIPULATED DURING PREPARATION OR INSERTION INTO THE PATIENT AT AN ANGLE, THIS TYPE OF DAMAGE COULD OCCUR. FURTHER EVALUATION REVEALED THAT THE FIRST RUBY COIL PET LOCK WAS INTACT, THE PUSHER ASSEMBLY WAS FRACTURED, AND THE PULL WIRE WAS PARTIALLY WITHDRAWN THROUGH THIS FRACTURE. THIS FAILURE WOULD HAVE CAUSED THE COIL TO DETACH, WHICH WAS NOT RETURNED FOR EVALUATION. THE THIRD RUBY COIL PUSHER ASSEMBLY WAS PULLED PROXIMALLY, BEYOND THE FRICTION LOCK ON THE INTRODUCER SHEATH. THIS TYPE OF FAILURE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE PUSHER ASSEMBLY IS PULLED WITH EXCESSIVE FORCE WHILE THE INTRODUCER SHEATH IS HELD STATIONARY, THIS TYPE OF FAILURE COULD OCCUR. BOTH THE SECOND AND THE THIRD RUBY COILS WERE ATTACHED TO THE DDT, AND THEIR RESPECTIVE PET LOCKS WERE INTACT. THE PENUMBRA INVESTIGATOR WAS SUCCESSFUL IN DETACHING THE COILS USING A DEMONSTRATION DETACHMENT HANDLE. THE HANDLE MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION AND, THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THESE DEVICES ARE 100% FUNCTIONALLY TESTED DURING IN-PROCESS INSPECTION. 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 3005168196-2015-00443 AND 00445.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DETACHING THE COILS. ADDITIONAL COILS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303463 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F42692

    Patients

    Seq Age Sex Outcome Treatment
    1