BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 8167196 · Received December 14, 2018

    Report

    Report Number
    3009698517-2018-00015
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053021916
    PMA / PMN Number
    K172390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON (B)(6) 2018, WE RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL (10MM X 27CM COMPLEX STANDARD COIL). "DURING EMBOLISATION, THE COIL "MADE" A NODE, AND WAS UNABLE TO BE RETRIEVED, THE COIL DETACHED SPONTANEOUSLY DURING RETRIEVAL OF MC / COIL SYSTEM. A STENT RETRIEVER WAS USED TO RETRIEVE THE COIL. ANOTHER ONE WAS USED." THE RESULTS OF OUR INVESTIGATION FOLLOWING RETURN OF THE AFFECTED DEVICE, ARE SUMMARIZED AS FOLLOWS: THE OPTIMA COMPLEX STANDARD COIL INVESTIGATION REVEALED THE DELIVERY PUSHER WITH THE IMPLANT COIL NOT ATTACHED. THE DETACHMENT SECTION PET WAS INTACT. THE SR THREAD THAT HOLDS THE IMPLANT COIL ATTACHED TO THE PUSHER COIL WAS FOUND FRACTURED DISTAL TO THE ATTACHMENT ZONE. THE END OF THE SR THREAD HAS AN APPEARANCE OF BEING STRETCHED. WITHOUT INSPECTION OF THE IMPLANT, FURTHER INVESTIGATION OF THE PRODUCT ISSUE IS NOT POSSIBLE. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATIONS RESULTS THE REPORTED COMPLAINT WAS CONFIRMED AS THE COIL WAS DETACHED FROM THE PUSHER, IT IS POSSIBLE THAT THE IMPLANT COIL WAS EXPOSED TO A FORCE THAT EXCEEDS TENSILE SPECIFICATIONS HOWEVER, WITHOUT THE IMPLANT COIL THE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED LOTS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER 121417B HAVE BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING EMBOLISATION, THE COIL "MADE" A NODE, AND WAS UNABLE TO BE RETRIEVED, THE COIL DETACHED SPONTANEOUSLY DURING RETRIEVAL OF MC / COIL SYSTEM. A STENT RETRIEVER WAS USED TO RETRIEVE THE COIL. ANOTHER ONE WAS USED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006091 OPTIMA COIL SYSTEM OPTIMA COIL HCG BALT USA, LLC OPTI1027CST10 121417B 00818053021916

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention