BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 2182905 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02564
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL END (APPROXIMATELY 5 CM) WITH THE EXPOSED CUTWIRE WAS RETURNED. THE REMAINDER OF THE DEVICE (WORKING LENGTH AND HANDLE)WAS CUT AWAY FROM THE DISTAL END OF THE DEVICE AND NOT RETURNED. THE EXPOSED CUT WIRE WAS BROKEN AND THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BURNT/BLACKENED. FURTHER ANALYSIS OF THE CUTTING WIRE FOUND IT BROKE AT APPROXIMATELY 23 MM FROM THE DISTAL PIERCE HOLE. THE OUTER DIAMETER (OD) OF THE EXPOSED CUT WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUT WIRE WAS BROKEN. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE BROKEN CUT WIRE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-02564 AND MFR. REPORT # 3005099803-2011-02565). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HYDRATOME RX SPHINCTEROTOMES WERE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN BOWING THE DEVICE TO PERFORM A SPHINCTEROTOMY, THE CUT WIRE BROKE. A SECOND HYDRATOME WAS OBTAINED AND USED TO CONTINUE THE PROCEDURE, HOWEVER, IT WAS THE NOTED THAT SMOKE WAS COMING OUT OF THE BIOPSY CHANNEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-02564 AND MFR. REPORT # 3005099803-2011-02582).

    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 M00583050 14210755

    Patients

    Seq Age Sex Outcome Treatment
    1