BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC BANDIT CATHETER

    MDR report key: 46075 · Received September 13, 1996

    Report

    Report Number
    2183819-1996-00015
    Event Type
    Malfunction
    Date Received
    September 13, 1996
    Date of Event
    July 10, 1996
    Report Date
    September 13, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT FULLY DEFLATE. THE BALLOON DEFLATED ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATION OCCURRRED. SAME CASE AS MFR. REPORT NO. 2183819-1996-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC BANDIT CATHETER PTCA CATHETER LOX SCIMED LIFE SYSTEMS, INC. NC B14 20/3.75 512441

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN