BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOLD¿ FIBERED

    MDR report key: 20722621 · Received November 19, 2024

    Report

    Report Number
    20722621
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    August 17, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    UDI-DI
    08714729983538
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    MULTIPLE COILS WOULD NOT DEPLOY FROM THE WIRE INSIDE THE PATIENT. 3 WERE REMOVED. THE 4TH ONE EVENTUALLY DEPLOYED AND MIGRATED FROM THE GASTRODUODENAL ARTERY TO THE HEPATIC ARTERY. STAFF TRIED TO SNARE THE COIL, BUT WAS UNSUCCESSFUL. STAFF HAD TO STOP THE PROCEDURE AFTER SEVERAL ATTEMPTS TO REMOVE THE COIL. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ FIBERED (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ PACKING (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ SOFT (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, EMBOLD¿ FIBERED (PER SITE REPORTER). REP PICKED UP... NO RGA # ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307485 EMBOLD¿ FIBERED DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC CORPORATION M001394240020060 34088360 08714729983538

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male