BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 9975410 · Received April 17, 2020

    Report

    Report Number
    3014162263-2020-00010
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 17, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053026324
    PMA / PMN Number
    K172390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GG
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO WHOM IT MAY CONCERN: ON MARCH 23TH, 2020, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL (6MM X 20CM COMPLEX STANDARD COIL). DETAILS REPORTED AS FOLLOWS: "THE COIL WAS RUPTURED DURING INSERTION PROCESS. PART OF THAT WAS LEFT IN ANEURYSM AND THE RES - OUT OF THE ANEURYSM. PATIENT GOT OPEN SURGERY TO REMOVE THE RESIDUAL PARTS." FOLLOW UP WAS DONE PERIODICALLY WITH THE CUSTOMER. DETAILS REPORTED AS FOLLOWS: THE ISSUE WAS, THAT THE COIL WAS RUPTURED - THE PART OF IT STAYED IN THE ANEURYSM, BUT THE OTHER PART - WAS OUT OF THE ANEURYSM. MEANING, IT WAS RUPTURED DURING INSERTION AND IT WAS NOT POSSIBLE TO INSERT IT INTO ANEURYSM, OR TO REMOVE IT. AFTER MULTIPLE TRIES, TO REMOVE THE COIL, THE ANEURYSM GOT RUPTURED. PATIENT HAS GOT AN OPEN SURGERY AND IS IN STILL IN CRITICAL CONDITION. THE COIL HAS RUPTURED DURING INSERTION - THE DISTAL PART REMAINED PARTIALLY IN ANEURYSM AND PARTIALLY - IN THE PARENT VESSEL, WHILE THE PROXIMAL PART (OF THE COIL ITSELF) REMAINED ATTACHED TO THE DELIVERY PART (PUSHER) AND WAS EXTRACTED OUT OF THE VESSEL. -THE ANEURYSM HAS RUPTURED DURING THE PROCEDURE. -MOST LIKELY, THE ANEURYSM DID NOT RUPTURE BECAUSE OF THE COIL, BUT AFTER MULTIPLE TRIES TO EXTRACT IT OUT. THE RESULTS OF OUR INVESTIGATION, ARE SUMMARIZED AS FOLLOWS: BALT USA HAS MADE FOUR SEPARATE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER REGARDING PATIENT STATUS AND PROCEDURE DETAILS, WITH NO CUSTOMER RESPONSE. AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED DEVICE WAS REPORTED UNAVAILABLE. ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. LACK OF ADDITIONAL INFORMATION AND DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED 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 060319A HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE COIL WAS RUPTURED DURING INSERTION PROCESS. PART OF THAT WAS LEFT IN ANEURYSM AND THE RES - OUT OF THE ANEURYSM. PATIENT GOT OPEN SURGERY TO REMOVE THE RESIDUAL PARTS."

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON (B)(6) 2020, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL (6MM X 20CM COMPLEX STANDARD COIL). DETAILS REPORTED AS FOLLOWS: "THE COIL WAS RUPTURED DURING INSERTION PROCESS. PART OF THAT WAS LEFT IN ANEURYSM AND THE RES - OUT OF THE ANEURYSM. PATIENT GOT OPEN SURGERY TO REMOVE THE RESIDUAL PARTS." THE RESULTS OF OUR INVESTIGATION, ARE SUMMARIZED AS FOLLOWS: -BALT USA HAS MADE FOUR SEPARATE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER REGARDING PATIENT STATUS AND PROCEDURE DETAILS, WITH NO CUSTOMER RESPONSE. -AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED DEVICE WAS REPORTED UNAVAILABLE. ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. LACK OF ADDITIONAL INFORMATION AND DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED 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 060319A HAS 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: "THE COIL WAS RUPTURED DURING INSERTION PROCESS. PART OF THAT WAS LEFT IN ANEURYSM AND THE RES - OUT OF THE ANEURYSM. PATIENT GOT OPEN SURGERY TO REMOVE THE RESIDUAL PARTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436586 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA, LLC OPTI0620CST10 060319A 00818053026324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention