BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONGOOSE SLIDING RIAL PTCA BALLOON CATHERTER

    MDR report key: 40995 · Received September 13, 1996

    Report

    Report Number
    2183541-1996-00171
    Event Type
    Malfunction
    Date Received
    September 13, 1996
    Report Date
    September 13, 1996
    Manufacturer
    SCHNEIDER (USA) CARDIOLOGY DIV.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BALLOON OF THIS DEVICE BURST DURING AN ANGIOPLASTY PROCEDURE, THERE HAS BEEN NO CLAIM OF INJURY RELATED TO THIS EVENT. NO ADD'L NFO HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONGOOSE SLIDING RIAL PTCA BALLOON CATHERTER PTCA BALLOON CATHETER LOX SCHNEIDER (USA) CARDIOLOGY DIV. MON-040 XUA945101

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO