BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC BANDIT CATHETER

    MDR report key: 46799 · Received September 19, 1996

    Report

    Report Number
    2183819-1996-00022
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 19, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.,
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT COMPLETELY DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON ENOUGH FOR REMOVAL. 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., NC B14 15/4.0 510831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN