BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIKRO-TIP ANGIOGRAPHIC CATHETER TRANSDUCER

    MDR report key: 374295 · Received January 26, 2002

    Report

    Report Number
    1625382-2002-00001
    Event Type
    Injury
    Date Received
    January 26, 2002
    Date of Event
    December 13, 2001
    Report Date
    January 11, 2002
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Product Code
    DXO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SPC-454F CATHETER WAS INSERTED THROUGH THE BRACHIAL ARTERY FOR THE PURPOSE OF LEFT VALVE ANGIOGRAPHY AND LV PRESSURE MEASURING. THE CATHETER (SPC-454) WAS INSERTED IN AORTA, PRESSURE WAS MEASURED SIMULTANEOUSLY BY THE FLUID FILLED METHOD. FIND IT EXTRAORDINARY, UNMATCHED BETWEEN "FF" METHOD MEASURING 140MM HG AND THE CATHETER MEASURING 200MM HG. THE CATHETER (SPC-454) WAS RETRIEVED WITHOUT USING GUIDEWIRE. THEN THE PHYSICIAN FOUND THE PIGTAIL WAS DETACHED. THE PHYSICIAN RECOGNIZED UNDER FLUOROSCOPY THAT THE DETACHED PIGTAIL WAS IN AROUND THE SUBCLAVIA. THEN, USING A SNARE CATHETER, PHYSICIAN MADE THE DETACHED PIGTAIL MOVE TO THE PROXIMAL (ELBOW) AND REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKRO-TIP ANGIOGRAPHIC CATHETER TRANSDUCER ANGIOGRAPHIC CATHETER TRANSDUCER DXO MILLAR INSTRUMENTS, INC. SPC-454F L024210

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention FLUID FILLED CATHETER.