BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC BANDIT CATHETER

    MDR report key: 40634 · Received September 9, 1996

    Report

    Report Number
    2183819-1996-00012
    Event Type
    Malfunction
    Date Received
    September 9, 1996
    Date of Event
    August 6, 1996
    Report Date
    September 5, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS DISCARDED BY THE HOSPITAL, SO NO RETURNED PRODUCRT ANALYSIS WILL BE AVAILABLE.

    Description of Event or Problem · 1

    DURING A PTCA PROCEDUE, THE BALLOON WOULD NOT DEFLATE. THEY CONTINUED TO PULL NEGATIVE PRESSURE UNTIL THE BALLOON DEFLATED ENOUGH TO REMOVE. NO PT INJURIES OR COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC BANDIT CATHETER PTCA CATHETER LOX SCIMED LIFE SYSTEMS, INC. NCB14 15/3.25 515018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN