BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE RETRIEVAL NITINOL BASKET V

    MDR report key: 18773128 · Received February 23, 2024

    Report

    Report Number
    2429304-2024-00118
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 11, 2024
    Report Date
    February 23, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LQR
    UDI-DI
    14953170395328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BALLOON RUPTURED DURING BALLOON SWEEP INVOLVING STONES. THE SINGLE USE RETRIEVAL BASKET BROKE. THE ISSUE OCCURRED WHEN THE BASKET WAS PLACED INTO THE DUCT TO RETRIEVE STONES DURING A THERAPEUTIC PROCEDURE. THE BASKET COULD NOT BE REMOVED DUE TO THE STONES, SO THE BASKET WAS CONNECTED TO THE EMERGENCY HANDLE, WHICH WAS WHEN THE BASKET BROKE. THE BASKET WAS THEN REMOVED WITH THE AID OF A EMERGENCY HANDLE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229338 SINGLE USE RETRIEVAL NITINOL BASKET V SINGLE USE RETRIEVAL BASKET LQR AOMORI OLYMPUS CO., LTD. FG-V451P 32K 17 14953170395328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention