BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC BANDIT CATHETER

    MDR report key: 41741 · Received August 29, 1996

    Report

    Report Number
    2183819-1996-00005
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    July 15, 1996
    Report Date
    August 2, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR OF THE BALLOON MATERIAL. THE DISTAL SECTION OF THE BALLOON WAS BUNCHED UP TOWARD THE DISTAL BOND. THE CORE WIRE, SPRING TIP, AND BALLOON BONDS REMAINED INTACT. THE CAUSE OF THE BALLOON DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A PTCA PROCEDURE, THE BALLOON WOULD NOT DEFLATE. AS THE GUIDE WIRE AND BALLOON CATHETER WERE PULLED BACK, THE BALLOON DEFLATED. 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 15/3.5 520651

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR