BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME¿ RX 44

    MDR report key: 2801046 · Received October 23, 2012

    Report

    Report Number
    3005099803-2012-04982
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS OVER 18 YEARS OF AGE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH/DISTAL TIP OF THE DEVICE WAS TWISTED AND THE GUIDEWIRE LUMEN WAS RIPPED FROM THE WIDE BROWN MARKER TO THE DISTAL TIP, TEARING THE DISTAL TIP. THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE DISTAL PIERCE HOLE, ELONGATING THE DISTAL PIERCE HOLE TO 18 MM PROXIMALLY FROM THE DISTAL PIERCE HOLE. THE TEAR CAUSED THE CUT WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE AND ALTERED THE EXPOSED CUTTING WIRE LENGTH TO BECOME SHORTER. FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DOES NOT MEET THE BOWING SPECIFICATION DUE TO THE MELTED EXTRUSION AND ALTERED EXPOSED CUTTING WIRE LENGTH. THE CONTINUITY BETWEEN THE 2-IN-1 CONNECTOR AND THE EXPOSED CUTTING WIRE WAS FOUND TO BE ABLE TO CONDUCT CURRENT INDICATING PROPER CONNECTIVITY OF THE DEVICE. THE RESISTANCE ACROSS THE 2-IN-1 CONNECTOR AND THE CUTTING WIRE WAS MEASURED AND WAS FOUND TO MEET SPECIFICATION. ALTHOUGH THE DEVICE FUNCTIONED AS INTENDED WITH RESPECT TO ELECTRICAL FUNCTIONALITY, THE ACTIVATED CUT WIRE MELTED/ELONGATED THE DISTAL PIERCE HOLE, WHICH CAUSED THE CUT WIRE TO BE SHORTENED. THIS AFFECTED THE TENSION OF THE CUT WIRE, WHICH HINDERED THE BOWING /CUTTING FUNCTIONALITY OF THE DEVICE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT DUE TO THE PROCEDURAL FACTORS/GENERATOR SETTINGS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER 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 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WOULD NOT CUT THROUGH TISSUE. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME. 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 "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WOULD NOT CUT THROUGH TISSUE. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME. 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 "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583050 0015290317

    Patients

    Seq Age Sex Outcome Treatment
    1