BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOLD¿ PACKING

    MDR report key: 22113891 · Received May 30, 2025

    Report

    Report Number
    22113891
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    February 26, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON INSERTED A MICROCATHETER CARRYING A COIL AND UPON DEPLOYING, THE COIL SNAPPED. THE SURGEON THEN REMOVED BOTH THE COIL IN ITS ENTIRETY AND THE CATHETER AS WELL. BOTH WERE REMOVED FROM THE FIELD AND SEQUESTERED TO BE HANDED OFF TO MANAGEMENT. NO PATIENT HARM, PATIENT DISCHARGED HOME NEXT DAY. EMBOLD COIL - REF # MOO1 -39426000060 LOT- 34866411. MICRO CATHETER ¿ REF # M001 181131 LOT# 35221747. MANUFACTURER RESPONSE FOR COIL, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27388 EMBOLD¿ PACKING DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC CORPORATION M001394260000600 34866411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown