BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALT PRESTIGE COIL SYSTEM

    MDR report key: 19033037 · Received April 2, 2024

    Report

    Report Number
    MW5153496
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 28, 2024
    Report Date
    March 28, 2024
    Manufacturer
    BALT USA, LLC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH ABDOMINAL AORTIC ANEURYSM BEING TREATED IN IR. ATTEMPTED TO DEPLOY COIL BUT WOULD NOT DEPLOY. DEVICE REMOVED AND ANOTHER DEVICE SUCCESSFULLY UTILIZED. BALT PRESTIGE PERIPHERAL EMBOLIZATION COIL LOT #F231000774, PRES0540CPKPLT 10/24/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83359 BALT PRESTIGE COIL SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC. PRES0540CPKPLT F231000774

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other