BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1991508 · Received February 15, 2011

    Report

    Report Number
    3005099803-2011-00495
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE COMPONENT CODE 430 RELATES TO THE DEVICE PROBLEM CODE 1069 FOR THE REPORTED EVENT OF WIRE BROKE.THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES WITHIN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS BOWED APPROXIMATELY 3-4 TIMES DURING THE PROCEDURE, THE CUTTING WIRE BROKE AT THE MIDDLE OF THE WIRE. NO PART OF THE WIRE DETACHED INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 GOOD.

    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 13942721

    Patients

    Seq Age Sex Outcome Treatment
    1