BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC BANDIT CATHETER

    MDR report key: 46069 · Received September 13, 1996

    Report

    Report Number
    2183819-1996-00019
    Event Type
    Malfunction
    Date Received
    September 13, 1996
    Date of Event
    August 9, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS THEN INFLATED TO 20 ATM (RBP=18 ATM), BUT THE DEFLATION WAS SLOW. NEGATIVE PRESSURE WAS APPLIED 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 15/3.0 524297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN