BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 8090315 · Received November 20, 2018

    Report

    Report Number
    3009698517-2018-00014
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053021480
    PMA / PMN Number
    K172390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (2MM X 8CM COMPLEX SUPER SOFT COIL). "2X8 CSS (AS FINAL COIL TO FINISH THE CASE AND COMPARE TO AXIUM PRIME ES) WAS PULLED GENTLY FROM HOOP AND HANDED TO PHYSICIAN. HE PLACED THE 2X8 CSS INTO ECHELON MICRO-CATHETER AND ADVANCED TO ANEURYSM(VENTRAL CAROTID WALL 8-9MM). DOCTOR ATTEMPTED TO PULL BACK COIL TO REPOSITION MICRO-CATHETER AND COIL PREMATURELY DETACHED IN THE MICRO-CATHETER. COIL WAS NOW FLOATING IN THE ICA- MULTIPLE ATTEMPTS WERE MADE TO SNARE, MEDTRONIC REP WAS CALLED TO BRING IN PIPELINE, DOCTOR WAS READY TO ADMIT TO SURGERY AND BEGIN FOREIGN BODY RETRIEVAL, AS HE STATED THIS WAS NOW CRITICAL. DR (B)(6) WAS ALSO PRESENT AND ALERTED THIRD DOCTOR WHO WAS MORE FAMILIAR WITH SNARES TO ASSIST IN THE CASE. DR (B)(6) AFTER SEVERAL ATTEMPTS WAS ABLE TO SNARE COIL AND ENDED THE CASE". THE RESULTS OF OUR INVESTIGATION FOLLOWING RETURN OF THE AFFECTED DEVICE, ARE SUMMARIZED AS FOLLOWS: IT WAS REPORTED THAT A SCEPTER BALLOON WAS USED FOR A WIDE NECK ANEURYSM. THE COIL DETACHED DURING REPOSITION AS THERE WAS NO ATTEMPT AT DETACHMENT VIA THE CONTROLLER WAS PERFORMED. THE DEVICE PUSHER WIRE WAS VISUALLY INSPECTED, AND IT APPEARED THAT THE SR THREAD HAD FRACTURED ABOUT 0.5MM DISTAL TO THE ATTACHMENT BOND. THE IMPLANT COIL WAS NOT RETURNED. THE STRETCHED RESISTANT THREAD END WAS WHITE/OPAQUE THE EXPECTED FAILURE MODE OF A TENSILE OVERLOAD FAILURE. BASED ON THE PROVIDED INFORMATION AND THE EVALUATION RESULTS THE REPORTED COMPLAINT WAS CONFIRMED. IT IS HIGHLY PROBABLE THAT THE SEPARATION CAME AS THE RESULT OF SIGNIFICANT STRAIN, APPLIED DURING REPOSITION OR MANIPULATION OF THE DEVICE ONCE INTRODUCED. ONCE DETACHED AFTER MANIPULATION THE IMPLANT COIL FEEL INTO THE ICA. 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. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. AT THIS TIME, NO SUCH INCREASE IN RATE OF OCCURRENCE HAS BEEN OBSERVED, HOWEVER THIS ISSUE WILL REMAIN SUBJECT TO CONTINUED TRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "2X8 CSS (AS FINAL COIL TO FINISH THE CASE AND COMPARE TO AXIUM PRIME ES) WAS PULLED GENTLY FROM HOOP AND HANDED TO PHYSICIAN. HE PLACED THE 2X8 CSS INTO ECHELON MICRO-CATHETER AND ADVANCED TO ANEURYSM (VENTRAL CAROTID WALL 8-9MM). DOCTOR ATTEMPTED TO PULL BACK COIL TO REPOSITION MICRO-CATHETER AND COIL PREMATURELY DETACHED IN THE MICRO-CATHETER. COIL WAS NOW FLOATING IN THE ICA- MULTIPLE ATTEMPTS WERE MADE TO SNARE, MEDTRONIC REP WAS CALLED TO BRING IN PIPELINE, DOCTOR WAS READY TO ADMIT TO SURGERY AND BEGIN FOREIGN BODY RETRIEVAL, AS HE STATED THIS WAS NOW CRITICAL. DR (B)(6) WAS ALSO PRESENT AND ALERTED THIRD DOCTOR WHO WAS MORE FAMILIAR WITH SNARES TO ASSIST IN THE CASE. DR (B)(6) AFTER SEVERAL ATTEMPTS WAS ABLE TO SNARE COIL AND ENDED THE CASE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930135 OPTIMA COIL SYSTEM OPTIMA COIL HCG BALT USA, LLC OPTI0208CSS10 100118A 00818053021480

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention