BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 9404828 · Received November 18, 2019

    Report

    Report Number
    9404828
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 15, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATH LAB PT FOR ATTEMPTED BALLOON DILATION OF LESION. UPON ATTEMPTING TO WITHDRAW DEFLATED BALLOON, A FRAGMENT OF THE BALLOON SHEARED OFF FROM THE DEVICE. UNABLE TO RETRIEVE IN CATH LAB. FRAGMENT RETRIEVED DURING CAGB PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131081 ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 1012274-20 90719G1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention