BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE 2L

    MDR report key: 12770131 · Received November 8, 2021

    Report

    Report Number
    12770131
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BALT USA LLC
    Product Code
    DQY
    UDI-DI
    00818053022968
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOCTOR WAS PERFORMING AN EMBOLIZATION PROCEDURE WITH A LIQUID EMBOLIC AGENT (ONYX) USING AN ECLIPSE 2L BALLOON CATHETERS THAT IS APPROVED FOR USE WITH THIS AGENT. IN THE COURSE OF THE PROCEDURE, A SMALL PORTION OF THE DEVICE BECAME EMBEDDED IN THE ONYX AND WAS RETAINED WITHIN PATIENT (TWICE, TWO SEPARATE CATHETERS WITH TWO SEPARATE FRAGMENTS, BOTH OF THE SAME BRAND). THIS IS NOT DESIGNED AS A BREAKAWAY CATHETER AND THEREFORE IS A DEVICE FAILURE, ALTHOUGH THIS IS A KNOWN OCCURRENCE IN THESE COMPLEX CASES. THE RETENTION IS NOT EXPECTED TO RESULT IN SIGNIFICANT INJURY AS THE FRAGMENTS ARE TOTALLY EMBEDDED IN THE ONYX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669960 ECLIPSE 2L CATHETER, PERCUTANEOUS DQY BALT USA LLC ECL2L6X12 F210100010 00818053022968

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA Male