BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT CATHETER

    MDR report key: 2440448 · Received January 19, 2012

    Report

    Report Number
    1318694-2012-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 7, 2011
    Report Date
    January 17, 2012
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K931009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO NUMED FOR EVAL. A SAMPLE DEVICE WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THE LABELED RBP FOR THIS CATHETER IS 10 ATM. THE SAMPLE CATHETER BURST AT 18 ATM WHICH IS ABOVE THE LABELED RBP. THIS CATHETER IS INTENDED FOR PTA USE ONLY. IT IS NOT INDICATED FOR USE WITH A STENT GRAFT. THIS CATHETER WAS BEING USED OFF LABEL.

    Description of Event or Problem · 1

    BALLOON WAS BEING USED TO EXPAND A STENT GRAFT. THE BALLOON FAILED. A SECOND BALLOON WAS USED AND IT FAILED TOO. THE PHYSICIAN STATED, "THE BALLOON CRACKED". A THIRD BALLOON WAS OPENED, THIS TIME A 16 X 4 AND THE DEVICE WORKED WITH NO PROBLEM. DEVICE #1 - IMPACT - (B)(4). DEVICE #2 - IMPACT - (B)(4). THIS REPORT IS FOR DEVICE #1. MDR 1318694-2012-00002 IS BEING SUBMITTED FOR DEVICE #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT CATHETER PTA CATHETER LIT NUMED, INC. 307 IM-1468

    Patients

    Seq Age Sex Outcome Treatment
    1