BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1133204 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03692
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUTTING WIRE WAS BROKEN, AND THE REMAINING PART OF THE CUTTING WIRE WAS BROKEN, AND THE REMAINING PART OF THE CUTTING WIRE HAD RETRACTED INTO THE DEVICE. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. THE TIP WAS RIPPED, BUT HAD NOT DETACHED FROM THE DEVICE; THE COMPLAINT COULD NOT BE CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. THE JULY 2008 15-MONTH JAGTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008 THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON A PT ON TWO DAYS EARLIER. ACCORDING TO THE COMPLAINANT, THE TIP OF THE DEVICE FELL OFF IN THE PT PRIOR TO USE. IT IS NOT KNOWN IF THE TIP WAS REMOVED FROM THE PT. THE PHYSICIAN REMOVED THE HYDROTOME RX SPHINCTEROTOME AND COMPLETED THE PROCEDURE WITH A SECOND HYDRATOME RX SPHINCTEROTOME. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583050 11762555

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other