BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME? RX 44

    MDR report key: 3172774 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05035
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THERE WERE SEVERAL TWISTS ALONG THE WORKING LENGTH AND THE CUTTING WIRE WAS BLACKENED. FUNCTIONAL EVALUATION FOUND THAT THE DEVICE BOWED MORE THAN 90 DEGREES AFTER BEING PUT THROUGH A DUODENOSCOPE, WHICH MEETS SPECIFICATION. THE RESISTANCE OF THE CUTTING WIRE WAS MEASURED AND FOUND TO MEET SPECIFICATIONS. THE LENGTH OF THE CUTTING WIRE WAS MEASURED AND FOUND TO MEET SPECIFICATIONS. THE DEVICE FUNCTIONED AS INTENDED WITH RESPECT TO ELECTRICAL FUNCTIONALITY. ALTHOUGH THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT, IT IS POSSIBLE THAT ANATOMICAL/PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. 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.

    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.

    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) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE WAS "NOT SUFFICIENT" TO CUT THE ORIFICE. THE DEVICE WOULD ONLY CUT WHEN ONLY THE VERY TIP OF THE CUTTING WIRE WAS IN CONTACT WITH THE ORIFICE. THE COMPLAINANT WAS UNABLE TO CONFIRM THE CAUSE OF THE EVENT BUT BELIEVES IT MAY BE RELATED TO THE CONMED GENERATOR USED DURING THE PROCEDURE. 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) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE WAS "NOT SUFFICIENT" TO CUT THE ORIFICE. THE DEVICE WOULD ONLY CUT WHEN ONLY THE VERY TIP OF THE CUTTING WIRE WAS IN CONTACT WITH THE ORIFICE. THE COMPLAINANT WAS UNABLE TO CONFIRM THE CAUSE OF THE EVENT BUT BELIEVES IT MAY BE RELATED TO THE CONMED GENERATOR USED DURING THE PROCEDURE. 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
    274201 HYDRATOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00583040 15733308

    Patients

    Seq Age Sex Outcome Treatment
    1