BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-TECH INC MAGIC TORQUE

    MDR report key: 16001 · Received June 8, 1994

    Report

    Report Number
    16001
    Event Type
    Injury
    Date Received
    June 8, 1994
    Date of Event
    June 3, 1994
    Report Date
    June 8, 1994
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PERIPHERAL ANGIOGRAM IN CARDIAC CATH LAB A TORQUE WIRE WAS INTRODUCED INTO A 5 FR CATHETER. THE WIRE WAS FRAYED WHEN REMOVED. AFTER THE PROCEDURE WAS TERMINATED THE PT'S RIGHT RADIAL PULSE WAS LOST. THE PT HAD TO GO TO SURGERY FOR EXPLORATION. A SEGMENT OF WIRE COATING WAS REMOVED FROM THE RADIAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH INC MAGIC TORQUE MAGIC TORQUE GUIDE WIRE DQX MEDI-TECH, INC. 46-591 165149

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R