BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1060787 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00685
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MANUFACTURE AND EXPIRATION DATE CANNOT BE DETERMINED. A SHIP HISTORY WAS PERFORMED AND FOUND THE LAST THREE LOTS SHIPPED TO THIS CUSTOMER. A DHR REVIEW AND HISTORY SEARCH WAS PERFORMED ON ALL THE THREE LOTS AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. A VISUAL EVAL FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE DISTAL END OF THE CUTTING WIRE WITH THE ANCHOR (NOTCH) HAD SEPARATED FROM THE DISTAL PIERCE HOLE OF THE EXTRUSION. SINCE THE PRODUCT IS 100% INSPECTED DURING MANUFACTURING, THE TWIST OBSERVED IN THE RETURNED DEVICE IS MOST LIKELY DUE TO CUSTOMER HANDLING DURING THE PROCEDURE. ANALYZING THE RETURNED DEVICE, IT APPEARS THAT THE CUTTING WIRE OVERHEATED/MELTED THE EXTRUSION NEAR THE DISTAL PIERCE HOLE CREATING A TEAR IN THE EXTRUSION FROM THE DISTAL PIERCE TO THE PROXIMAL PIERCE HOLE, AND DETACHED ITSELF WITH THE ANCHOR. THE CUTTING WIRE WAS INTACT AND NOT BROKEN. SO THERE WAS NO POSSIBILITY OF THE BROKEN WIRE REMAINING INSIDE THE PT SINCE THE CUTTING WIRE HAD ONLY DISLODGED FROM THE EXTRUSION, BUT WAS STILL ATTACHED TO THE PROXIMAL PIERCE AND WAS FOUND TO BE INTACT. BASED ON THE EVENT DESCRIPTION, IT APPEARS THAT THE CUSTOMER FOUND THE WIRE DETACHED FROM EXTRUSION AND PRESUMED IT WAS BROKEN. THE EXTRUSION SHOWED EVIDENCE OF BIENG OVERHEATED/MELTED AND THE CUTTING WIRE APPEARED TO BE BLACKENED/CHARRED. BASED ON OTHER COMPALINTS RECEIVED FOR TOME DEVICES WHERE THE CUTTING WIRE APPEARED TO BE OVERHEATED, BLACKENED/CHARRED AND/OR BROKEN, THE POTENTIAL ROOT CAUSES WERE IDENTIFIED TO BE THE ENERGIZED CUTTING WIRE COMING INTO CONTACT WITH SOME PART OF THE SCOPE OR IMPROPER POWER SETTINGS USED ON THE GENERATOR. IN THIS COMPLAINT, THE CUTTING WIRE APPEARED BURNT/CHARRED MOST LIKELY DUE TO THE HIGHER SETTINGS ON THE GENERATOR/ RESIDUE BUILDUP. THE DIRECTIONS FOR USE (DFU) INSTRUCTS THE PHYSICIAN TO USE THE APPROPRIATE POWER SETTINGS AND ALSO PROVIDES REFERENCES FOR THE POWER SETTINGS. THE ROOT CAUSE FOR THIS FAILURE MODE IS UNDETERMINABLE SINCE IT CANNOT BE DETERMINED WHAT FACTORS CAUSED THE CUTTING WIRE TO MELT THE EXTRUSION. THE FACTORS THAT COULD POTENTIALLY CAUSE EXTRUSION TO MELT ARE USER ERROR (HIGHER POWER SETTING OF GENERATOR), DEVICE DESIGN OR MANUFACTURING (QUALITY OF EXTRUSION).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), THE PHYSICIAN PERFORMED A SPHINCTEROTOMY SUCCESSFULLY. AFTER THE PHYSICIAN NOTICED THE CUT WIRE ON THE HYDRATOME RX SPHINCTEROTOME WAS BROKEN OFF. THE PHYSICIAN TRIED TO LOOK FOR THE CUT WIRE INSIDE THE PT, BUT WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR