BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA BALLOON CATHETER

    MDR report key: 1190579 · Received October 6, 2008

    Report

    Report Number
    3005099803-2008-05073
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    July 4, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED BUT NOT WRAPPED AROUND THE SHAFT. THERE WERE 2 PINHOLES VISIBLE IN THE BALLOON MATERIAL APPROXIMATELY 15MM PROXIMAL TO THE TIP OF THE DEVICE WHEN THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE. THE SURROUNDING BALLOON MATERIAL DID NOT CONTAIN ANY ABNORMALITIES WHICH MAY HAVE CONTRIBUTED TO THE DEFECT. DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE NOTED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE HANDLING DAMAGE BECAUSE THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE WITHOUT PT CONTACT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON INFO OBTAINED DURING THE DEVICE ANALYSIS IN 2008. IT WAS REPORTED THAT DURING A URETERAL STENTING PROCEDURE, THE BALLOON FAILED TO INFLATE. THE TARGET LESION WAS IN AN UNSPECIFIED URETERAL LOCATION. A U2Q/6-4/5.8/75 UROMAX ULTRA BALLOON CATHETER HAD BEEN UNPACKED AND TESTED; HOWEVER, THE BALLOON FAILED TO INFLATE. THE PHYSICIAN CHOSE NOT TO USE THE BALLOON TO PREDILATE THE LESION. THE BALLOON CATHETER DID NOT COME INTO CONTACT WITH THE PT. THE PROCEDURE WAS COMPLETED WITH DIRECT STENTING USING AN UNSPECIFIED TYPE OF 7 FRENCH URETERAL STENT. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE". RETURNED PROD ANALYSIS REVEALED 2 PINHOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROMAX ULTRA BALLOON CATHETER EZN BOSTON SCIENTIFIC M0062251020 8003608

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR