BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE BALLOON CATHETER

    MDR report key: 224042 · Received May 13, 1999

    Report

    Report Number
    1220452-1999-00025
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Date of Event
    April 28, 1999
    Report Date
    April 29, 1999
    Manufacturer
    MEDTRONIC VASCULAR INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE MFR THAT DURING THE PROCEDURE THE BALLOON FAILED TO DEFLATE. REPORTEDLY, THE PHYSICIAN DISCONNECTED THE CATHETER FROM THE INFLATION DEVICE AND WAS THEN ABLE TO DEFLATE THE BALLOON ENOUGH TO REMOVE IT. THERE WAS NO REPORT OF PT INJURY, AND THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE BALLOON CATHETER BALLOON CATHETERS LOX MEDTRONIC VASCULAR INC. NA 44LIB176

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR