BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALT COIL

    MDR report key: 17682898 · Received September 1, 2023

    Report

    Report Number
    MW5145144
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 25, 2023
    Report Date
    August 28, 2023
    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

    COIL WAS PLACED IN CATHETER AS USUAL. COIL DID NOT DETACH, ANOTHER DETACHER USED AS AN ATTEMPT TO DETACH COIL WITH NO SUCCESS. THE COIL WAS THEN TAKEN OUT OF THE CATHETER/PATIENT AND OFF OF THE STERILE FIELD. COIL FAILED TO DETACH. 3.5X30 PRESTIGE COIL SYSTEM (BALT) F230501011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870025 BALT COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC. 3.5X30 PRESTIGE COIL SYSTEM (BALT) F230501011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other