BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 10456781 · Received August 26, 2020

    Report

    Report Number
    3014162263-2020-00017
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 5, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BALT USA
    Product Code
    HCG
    UDI-DI
    00818053022067
    PMA / PMN Number
    K172390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BALT USA'S REFERENCE NUMBER: (B)(4). TO WHOM IT MAY CONCERN: ON AUGUST 06, 2020, BALT USA HAS BEEN NOTIFIED OF AN EVENT REGARDING THE USE OF A SINGLE OPTIMA COIL. DETAILS REPORTED AS FOLLOWS: "THE CASE WAS ACOM NARROW NECK ANEURYSM MEASURING 25MMX18MM AND NECK MEASURED 6MM.THE PHYSICIAN PLANNED TO DO SIMPLE COILING OF THE ANEURYSM.THE SUPPORT HARDWARE WAS 8F NEURONMAX ,6F FARGOMAX ,VASCO 10D & TRAXCESS GUIDE WIRE .THE COILS USED WERE COMPLEX18 22X65-2NO,20X65-2NO,14X47-1NO,COMPLEX10STANDARD10X34-1NO. THE LAST COIL WAS OPTIMA HELICAL STANDARD10X30-1NO TO COMPLETE THE PROCEDURE. OUT OF THE COMPLEX18- 22X65 GOT PRE MATURELY DETACHED AND THE SAME WAS RETRIEVED BY USING VASCO 21 AND SOLITAIRE STENT RETRIEVER. WE WERE NOT ABLE TO COLLECT THE DEVICE PUSHWIRE, COILS AND MICRO CATH AS THE PATIENT WAS SUSPECTED FOR COVID 19 AND ALL THE THEM WERE DISCARDED AS PER HOSPITAL POLICY. BUT WE WERE ABLE TO GET THE RECORDED IMAGES." AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS THE DEVICE WAS UNAVAILABLE FOR RETURN. BASED ON THE PROVIDED INFORMATION, ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. LACK OF DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED ISSUE. REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT WAS PERFORMED. CUSTOMER FEEDBACK HAS BEEN NOTED FOR LOT 101619B; HOWEVER, THERE IS NO IN-PROCESS ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. THIS LOT WILL REMAIN SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH AN AUTOMATED REPORTING SYSTEM FROM ACTIVE CLINICAL STUDY: "THE CASE WAS ACOM NARROW NECK ANEURYSM MEASURING 25MMX18MM AND NECK MEASURED 6MM.THE PHYSICIAN PLANNED TO DO SIMPLE COILING OF THE ANEURYSM.THE SUPPORT HARDWARE WAS 8F NEURONMAX ,6F FARGOMAX ,VASCO 10D & TRAXCESS GUIDE WIRE .THE COILS USED WERE COMPLEX18 22X65-2NO,20X65-2NO,14X47-1NO,COMPLEX10STANDARD10X34-1NO. THE LAST COIL WAS OPTIMA HELICAL STANDARD10X30-1NO TO COMPLETE THE PROCEDURE. OUT OF THE COMPLEX18- 22X65 GOT PRE MATURELY DETACHED AND THE SAME WAS RETRIEVED BY USING VASCO 21 AND SOLITAIRE STENT RETRIEVER. WE WERE NOT ABLE TO COLLECT THE DEVICE PUSHWIRE, COILS AND MICRO CATH AS THE PATIENT WAS SUSPECTED FOR COVID 19 AND ALL THE THEM WERE DISCARDED AS PER HOSPITAL POLICY. BUT WE WERE ABLE TO GET THE RECORDED IMAGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917756 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA OPTI2265COM18 101619B 00818053022067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention