BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1060754 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00695
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE HYDRATOME RX SPHINCTEROTOME WAS INSERTED INTO THE SCOPE AND CANNULATED THE COMMON BILE DUCT (CBD). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE GUIDE WIRE WAS ADVANCED INTO THE CBD BUT THE TIP OF THE CANNULA WAS NOT BENDING NORMALLY (BOWED) AND TO PERFORM THE SPHINCTEROTOMY THERE WAS MINIMAL PULLING ON THE CUTTING WIRE TO ADEQUATELY CUT THE SPHINCTER OPEN." THERE WAS MINIMAL PULLING ON THE CUT WIRE, NOT BY THE HANDLER BUT THE ACTION OF THE INSTRUMENT. THE HANDLER WAS PULLING FULLY ON THE HANDLE IN ORDER TO GET THE OPTIMAL BLEEDING OF THE SPHINCTEROTOME BUT THERE WAS A MINIMAL "PULL" AT THE TIP OF THE SPHINCTEROTOME IN ORDER TO GET THE TIP TO BEND ADEQUATELY". THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH A COOK FUSION SPHINCTEROTOME. THE PT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583000 11576262

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR