BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 7302723 · Received February 21, 2018

    Report

    Report Number
    7302723
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    February 13, 2018
    Report Date
    February 15, 2018
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIAL NEEDLE ACCESSED BRACHIAL ARTERY UNDER ULTRASOUND GUIDANCE. BALANCE MIDDLEWEIGHT (BMW) WIRE WAS THEN ADVANCED AND VISUALIZED UNDER FLUOROSCOPY. HOWEVER, THERE WAS A 90 DEGREES BEND IN THE BMW WIRE. ON REMOVAL, IT WAS NOTED THAT THE WIRE SHEARED OFF AND ONLY PART OF THE WIRE WAS RETRIEVED. FEMORAL ARTERIAL ACCESS WAS OBTAINED. ANGIOGRAPHY REVEALED THE WIRE HAD ENTERED THE BRACHIAL ARTERY ABOVE THE AV FISTULA, TURNED 180 DEGREES, WENT THROUGH THE AV FISTULA AND INTO THE SUBCLAVIAN VEIN. A SNARE CATHETER ADVANCED IN THE VENOUS SYSTEM AND REMAINING WIRE WAS RETRIEVED. NO COMPLICATIONS TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128662 ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE DQX ABBOTT VASCULAR 7121372

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R