BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 2040150 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-00959
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELTED EXTRUSION, CREATED A TEAR MEASURING APPROXIMATELY 5 MM PROXIMALLY FROM THE DISTAL PIERCE HOLE. THIS TEAR CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE AND SHORTENED THE EXPOSED CUTTING WIRE LENGTH, WHICH NOW DOES NOT MEET SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT MEET THE BOWING SPECIFICATION AS A RESULT OF THE MELTED/SPLIT EXTRUSION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE CUT WIRE WOULD NOT BOW, HOWEVER, THIS WAS ATTRIBUTED TO MELTED/SPLIT EXTRUSION. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED, THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING THE SPHINCTEROTOMY, THE TOME FAILED TO BOW. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SATISFACTORILY COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. THE ACCOUNT REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; MELTED EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583040 13909196

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR