BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 10213644 · Received June 30, 2020

    Report

    Report Number
    3014162263-2020-00013
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 16, 2020
    Manufacturer
    BALT USA
    Product Code
    HCG
    UDI-DI
    00818053021596
    PMA / PMN Number
    K172390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON JUNE 4, 2020, BALT USA HAS BEEN NOTIFIED OF AN EVENT REGARDING THE USE OF A SINGLE OPTIMA COIL (4MM X 8CM COMPLEX SUPER SOFT). DETAILS REPORTED AS FOLLOWS: "RUPTURE DURING COILING. MANAGED BY TEMPORARY OCCLUSION OF PARENT ARTERY WITH BALLOON MICRO CATHETER AND COILING. SUBARACHNOID HAEMORRHAGE WITHOUT SYMPTOMS." THE FOLLOWING WAS PROVIDED JUNE 17, 2020: "THE HOSPITAL DISCHARGE WAS DONE ON (B)(6) 2020 WITH MRS. = 0. NO NEW HOSPITALIZATION SINCE THE DISCHARGE. GRADE 0-NO SYMPTOMS AT ALL. GRADE 1-NO SIGNIFICANT DISABILITY DESPITE SYMPTOMS, ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES. GRADE 2-SLIGHT DISABILITY, UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE. GRADE 3-MODERATE DISABILITY, REQUIRING SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE. GRADE 4-MODERATELY SEVERE DISABILITY, UNABLE TO WALK WITHOUT ASSISTANCE AND UNABLE TO ATTEND TO OWN BODILY NEEDS WITHOUT ASSISTANCE. GRADE 5-SEVERE DISABILITY, BEDRIDDEN, INCONTINENT AND REQUIRING CONSTANT NURSING CARE AND ATTENTION. GRADE 6-DEATH." 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 DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER F200100050 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: "RUPTURE DURING COILING. MANAGED BY TEMPORARY OCCLUSION OF PARENT ARTERY WITH BALLOON MICRO CATHETER AND COILING. SUBARACHNOID HEMORRHAGE WITHOUT SYMPTOMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674548 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA OPTI0408CSS10 F200100050 00818053021596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention