BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTA DILATATION CATHETER

    MDR report key: 1070740 · Received July 1, 2008

    Report

    Report Number
    1820334-2008-00347
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 30, 2008
    Manufacturer
    COOK INC.
    Product Code
    DQY
    PMA / PMN Number
    K052036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. THIS PRODUCT LINE IS INSPECTED ENSURING THE BALLOON PROPERLY INFLATES TO THE SPECIFIED PARAMETERS, REWRAPS PROPERLY WHEN NEGATIVE PRESSURE IS APPLIED AND VISUALLY VERIFYING THE SHAFT MATERIAL IS FREE FROM SURFACE IMPERFECTIONS. IN ADDITION, THE LUMEN OF THE BALLOON CATHETER IS WIRED 100%. WE ENCOURAGE THE CUSTOMER TO REFERENCE THE ATTACHED INFORMATION FOR USE BOOKLET PRIOR TO USE. WE STATE UNDER THE HEADING. INSTRUCTIONS FOR USE, BALLOON PREPARATION, LINE 4, "PREPARE BALLOON LUMEN WITH STANDARD CONTRAST-SALINE MIXTURE AS FOLLOWS: FILL A SYRINGE OF APPROPRIATE SIZE WITH 1:1 MIXTURE OF CONTRAST MEDIUM AND NORMAL SALINE. "WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PHYSICIAN WAS FINISHING THE PROCEDURE, HE ATTEMPTED TO ASPIRATE THE FLUID FROM THE BALLOON. THE BALLOON WOULD NOT DEFLATE, THE PHYSICIAN RUPTURED THE BALLOON TO BE ABLE TO REMOVE IT. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTA DILATATION CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC. 2036829

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention