BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 8038452 · Received November 5, 2018

    Report

    Report Number
    3009698517-2018-00013
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 25, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053021725
    PMA / PMN Number
    K172390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 (4MM X 7CM COMPLEX SOFT COIL). "COIL DID NOT DETACH, WHEN IT WAS BEING PULLED BACK INTO THE CATHETER BEFORE THE PHYSICIAN REALIZED IT WAS NOT DETACHED, IT DETACHED, AND PART OF THE COIL WAS IN THE MICRO CATHETER. THE PHYSICIAN PUSHED THE COIL INTO THE ANEURYSM USING THE COIL PUSHER WIRE. IT PUSHED OUT INTO THE PARENT ARTERY AND WAS THEN SNARED OUT. THEY PHYSICIAN COMPLETED THE PROCEDURE WITH NO PATIENT COMPLICATION". THE RESULTS OF OUR INVESTIGATION FOLLOWING RETURN OF THE AFFECTED DEVICE, ARE SUMMARIZED AS FOLLOWS: THE VISUAL ANALYSIS REVEALED THE DELIVERY PUSHER WITH THE IMPLANT COIL NOT ATTACHED. THE DISTAL END OF THE IMPLANT COIL EXHIBITED A BLOOMING TIP ON THE STRETCH-RESISTANT THREAD. BY THE CONDITION OF THE DEVICE IT IS CONFIRMED THAT THE COIL DETACHED BY ELECTRICAL CURRENT HOWEVER, IT IS UNKNOWN IF IT WAS DETACHED AT THE FIRST ATTEMPT. THE PHYSICIAN STATED THAT THE COIL WAS PUSHED INTO THE ANEURYSM USING THE COIL PUSHER WIRE. IT PUSHED OUT INTO THE PARENT ARTERY AND WAS THEN SNARED OUT. THE ANEURYSM DIMENSIONS WERE 3.5MM X 5MM CLOSE TO A WIDE NECK WITH NO STENT PLACED TO REINFORCE THE COILS. THE COIL PROLAPSE MAY RESULT FROM A VARIETY OF CAUSES, INCLUDING SIZE MISMATCH BETWEEN THE COILS AND ANEURYSM, INADEQUATE POSITION OF THE MICROCATHETER, COIL INSTABILITY AFTER DETACHMENT, EXCESSIVE EMBOLIZATION, MICROCATHETER OR STENT RELATED PROBLEMS, OR FROM BEING PUSHED BY SUBSEQUENT COIL EMBOLIZATION. PROLAPSE OCCURRED IN ANEURYSMS WITH WIDE OR "LOOSE" NECKS. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION RESULTS THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THE POTENTIAL ROOT CAUSE TO THE UNEXPECTED DETACHMENT WAS DUE TO THE POLYMER SR THREAD DIAMETER INCREASING AFTER DETACHMENT. HOWEVER, IT CANNOT BE DETERMINED WHAT CAUSED THE COIL TO FALL INTO THE PARENT ARTERY AFTER DETACHMENT. 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 100118A HAVE BEEN MADE FOR THE SAME ISSUE. 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 (LOT NUMBER) 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: "COIL DID NOT DETACH, WHEN IT WAS BEING PULLED BACK INTO THE CATHETER BEFORE THE PHYSICIAN REALIZED IT WAS NOT DETACHED, IT DETACHED, AND PART OF THE COIL WAS IN THE MICRO CATHETER. THE PHYSICIAN PUSHED THE COIL INTO THE ANEURYSM USING THE COIL PUSHER WIRE. IT PUSHED OUT INTO THE PARENT ARTERY AND WAS THEN SNARED OUT. THEY PHYSICIAN COMPLETED THE PROCEDURE WITH NO PATIENT COMPLICATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879548 OPTIMA COIL SYSTEM OPTIMA COIL HCG BALT USA, LLC OPTI0407CSF10 100118A 00818053021725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention