BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-FORCE BALLOON DILATION CATHETER

    MDR report key: 1160468 · Received September 12, 2008

    Report

    Report Number
    1018233-2008-00064
    Event Type
    Injury
    Date Received
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EZN
    PMA / PMN Number
    K050875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK, THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE BALLOON PROTECTOR HAS A FLARED EDGE THAT OPENS UP WHICH WOULD MAKE IT DIFFICULT TO INSERT INTO THE PT. SINCE THE PROTECTOR COVERS THE FULL LENGTH OF THE BALLOON, THE BALLOON WOULD NOT BE ABLE TO INFLATE IF COVERED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THE DEVICE STATES AS THE FIRST STEP TO REMOVE THE PROTECTIVE SHEATH. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT IS MOST LIKELY DUE TO THE USER FAILING TO REMOVE THE PROTECTIVE COVER ACCORDING TO THE INSTRUCTIONS WHICH ACCOMPANY THE PRODUCT. BASELINE REPORT ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHROSTILITHOTOMY, URETEROSCOPY, CYSTOSCOPY, AND URETERAL STENT PLACEMENT PROCEDURE FOR KIDNEY STONES IN 2007, THE SHEATH COVERING FROM THE BALLOON PACKAGING WAS LEFT IN THE PT'S LEFT UPPER URETER. THE PT HAS A 7 YR HISTORY OF KIDNEY STONES, BUT THIS WAS HER FIRST PROCEDURE EVER INVOLVING USE OF A DILATION CATHETER. THE PT BEGAN EXPERIENCING SIMILAR KIDNEY STONE SYMPTOMS AND IN '08 HAD A CAT SCAN. THE PT WAS NOTED TO HAVE KIDNEY STONES, AND ALSO A CYLINDRICAL STRUCTURE WAS NOTED IN HER LEFT UPPER URETER. AT APPROXIMATELY 36 DAYS LATER, PT HAD A URETEROSCOPY AND CYSTOSCOPY FOR STONE REMOVAL AND REMOVAL OF A RETAINED FOREIGN BODY BY ANOTHER DR. THE OBJECT WAS ABLE TO BE REMOVED DURING THE CYSTOSCOPY PROCEDURE AND NO INCISIONS OR ADDITIONAL INVASIVE PROCEDURES WERE NEEDED FOR REMOVAL. THE FOREIGN BODY WAS DETERMINED TO BE THE SHEATH COVERING FROM THE BALLOON PACKAGING WHICH HAD APPARENTLY NOT BEEN REMOVED FROM THE BALLOON PRIOR TO USE AND WAS INSERTED INTO THE PT AND REMAINED IN PT UPON COMPLETION OF INITIAL PROCEDURE IN 2007. THE SHEATH WAS INTACT UPON REMOVAL FROM THE PT AND WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-FORCE BALLOON DILATION CATHETER EZN C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention