BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX CANNULATING SPHINCTEROTOME

    MDR report key: 1063570 · Received June 20, 2008

    Report

    Report Number
    3005099803-2008-00861
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO RELATED ISSUES TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND ONE OTHER COMPLAINT AGAINST THIS LOT FOR THE BOWING ISSUE FROM THE SAME CUSTOMER. THE JAGTOME WAS RECEIVED IN A SEPARATE ZIPLOC BAG WITH ANOTHER DEVICE. RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE. A VISUAL EVAL FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUTTING WIRE APPEARED TO HAVE MELTED THE EXTRUSION AT THE DISTAL PIERCE HOLE. 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. IT APPEARS THAT THE CUTTING WIRE HAD OVERHEATED AND MELTED THE EXTRUSION NEAR THE DISTAL PIERCE HOLE CREATING A TEAR, MEASURING APPROXIMATELY 7 MM IN THE EXTRUSION. MOST LIKELY DUE TO THE HIGHER POWER SETTING OF THE GENERATOR, THE CUTTING WIRE MAY HAVE OVERHEATED AND MELTED THE EXTRUSION NEAR THE DISTAL PIERCE HOLE. THE TEAR AT THE DISTAL PIERCE HOLE ALTERED THE EXPOSED CUTTING WIRE LENGTH TO BECOME SHORTER, WHICH NOW MEASURED APPROXIMATELY 12 MM, AND NOW IS OUTSIDE THE MANUFACTURING SPECIFICATION OF 20MM +/- 2 MM. THE SHORTENED CUTTING WIRE WHICH WAS ALSO BENT HINDERED THE DEVICE FROM BOWING WHEN ACTIVATED WITH THE HANDLE. THEREFORE, THE REPORTED COMPLAINT OF NOT BOWING THE DEVICE IS CONFIRMED. THE EXTRUSION APPEARS TO HAVE MELTED AND TORN DUE TO THE HIGHER POWER SETTINGS OF THE GENERATOR. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT SINCE THE FAILURE OF THE DEVICE IS DUE TO THE HIGHER POWER SETTINGS OF THE GENERATOR. THE DIRECTIONS FOR USE (DFU) INSTRUCTS THE PHYSICIAN TO USE THE APPROPRIATE POWER SETTINGS AND ALSO PROVIDES REFERENCES FOR THE POWER SETTINGS. MDR REFERENCE NUMBER: 3005099803-2008-00835/TW 717332.

    Description of Event or Problem · 1

    A JAGTOME RX AND AN AUTOTOME RX SPHINCTEROTOME WERE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE JAGTOME WAS INSERTED INTO THE SCOPE TO CANNULATE COMMON BILE DUCT (CBD) AND THE PHYSICIAN WAS ABLE TO CLOSE IT. "THE PHYSICIAN WAS NOT ABLE TO CLOSE IT THE SECOND TIME AS IT WOULD NOT TIGHTEN BACK UP AGAIN. AN AUTOTOME WAS INSERTED OVER THE EXISTING WIRE FROM THE JAGTOME AND THE AUTOTOME WOULD NOT FLEX AT ALL." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE." THE SUBJECT DEVICE WAS RETURNED TO FACILITY FOR THE EVAL. THE INVESTIGATION RESULTS REVEALED THAT THE EXPOSED CUTTING WIRE APPEARED TO HAVE MELTED THE EXTRUSION AT THE DISTAL PIERCE HOLE. THIS EVENT WAS ASSESSED AS A REPORTABLE IN 2008, BASED ON THIS INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX CANNULATING SPHINCTEROTOME KNS BOSTON SCIENTIFIC M00573040 11489582

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK