BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER

    MDR report key: 1668802 · Received April 12, 2010

    Report

    Report Number
    1220948-2010-00002
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 9, 2010
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GBZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MDR DECISION TREE FOR COMPLAINT REPORTING WAS REVIEWED AND THE DEVICE COMPLAINT IS CONSIDERED TO BE REPORTABLE. THE MALFUNCTION WAS FOUND DURING THE PROCEDURE. THE PT WAS NOT INJURED AND PROCEDURE WAS FINISHED WITH ANOTHER DEVICE. THE DEVICE WAS RETURNED FOR THE EVAL. WE WERE ABLE TO CONFIRM THE FAILURE: FAILURE AT PROXIMAL BOND. THE BALLOON WAS NOT RUPTURED AND WAS NOT DETACHED. THEREFORE, WE CAN CONCLUDE THAT NO PIECES OF THE DEVICE WERE LEFT IN THE PT. THE ROOT CAUSE OF MALFUNCTION IS INCONCLUSIVE. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS USED DURING THE PROCEDURE CONTRIBUTED TO THE FAILURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL MFG AND QUALITY INSPECTIONS WERE COMPLETED IN ACCORDANCE TO THE INSTRUCTIONS. WE HAVE NOT SEEN SIMILAR COMPLAINT IN THE LAST 12 MONTHS. PLEASE NOTE THAT THERE WAS NO PT INJURIES HAPPENED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHEN THE SURGEON WAS USING THE CATHETER TO REMOVE A STONE, THE BALLOON RUPTURED. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER CHOLANGIOGRAM CATHETER GBZ LEMAITRE VASCULAR RST1806

    Patients

    Seq Age Sex Outcome Treatment
    1