BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME¿ RX 44

    MDR report key: 2181611 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02589
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL TIP WITH EXPOSED CUTTING WIRE WERE TWISTED. DURING A FUNCTIONAL TESTING, IT WAS FOUND THAT THE INITIAL ORIENTATION DID NOT MEET THE ORIENTATION SPECIFICATION. THE ORIENTATION OF THE DISTAL TIP COULD BE ADJUSTED LEFT OR RIGHT BY ROTATING THE HANDLE, BUT COULD NOT BE SET WITHIN SPECIFICATION DUE TO THE TWISTED WORKING LENGTH AND CUTWIRE. A SECOND FUNCTIONAL EVALUATION FOUND THAT THE DEVICE MET THE MINIMUM BOWING SPECIFICATION BUT THE BOWING WAS NOT IN PLANE. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE BOWED INCORRECTLY. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE CONDITION OF THE DEVICE 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

    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 RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED WHEN THE CUT WIRE WAS BOWED, IT BOWED TO THE WRONG SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED WHEN THE CUT WIRE WAS BOWED, IT BOWED TO THE WRONG SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. 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.

    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 M00583040 14041219

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR