BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER PLUS CATHETER

    MDR report key: 11744479 · Received April 28, 2021

    Report

    Report Number
    MW5101060
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 27, 2021
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIONEER CATHETER DISFUNCTION WHICH CAUSED US TO END THE CASE. THE WIRE COILED DURING REMOVAL AND WAS STUCK INSIDE THE CATHETER. NO HARM WAS DONE TO THE PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638575 PIONEER PLUS CATHETER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX VOLCANO CORPORATION 4970246

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention