BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTS CATHETER

    MDR report key: 2466113 · Received February 9, 2012

    Report

    Report Number
    1318694-2012-00004
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    December 1, 2011
    Report Date
    February 9, 2012
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CATHETER WAS DISCARDED AND WILL NOT BE RETURNED. A RESERVE SAMPLE WAS EVALUATED BOTH WITH A 20CC SYRINGE, WHICH IS WHAT WAS USED BY THE PHYSICIAN ACCORDING TO THE COMPLAINT REPORT, AND WITH AN INFLATION DEVICE WITH PRESSURE GAUGE AS IS RECOMMENDED IN THE INSTRUCTIONS FOR USE. THE COMPARATIVE CATHETER WAS PURGED AND INFLATED WITH A 20CC SYRINGE FILLED WITH ROOM TEMPERATURE WATER. THE BALLOON WITHSTOOD THE INFLATION AND WAS MEASURED AT 24.7MM. THE CATHETER WAS THEN DEFLATED AND THEN REINFLATED USING A CALIBRATED INFLATION DEVICE WITH PRESSURE GAUGE. THE CATHETER BURST AT 2.5 ATM WHICH IS OVER THE LABELED RBP OF 1.5 ATM. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    "WHILE THE PHYSICIAN INJECTED TO THE SIZING BALLOON, IT EXPLODED. THE EXPLOSION HAPPENED BEFORE THE BALLOON WAS STRETCHED TO THE ACTUAL SIZE (25MM). A 20CC SYRINGE WAS USED." BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTS CATHETER SIZING CATHETER LIT NUMED, INC. 360 OS-1256

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR