BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1170644 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04592
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. THE 2008 15-MONTH JAGTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THE HYDRATOME RX SPHINCTEROTOME IS INCLUDED IN THE JAGTOME PRODUCT FAMILY.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MFR REPORT #3005099803-2008-04591 FOR A DESCRIPTION OF THE FIRST EVENT. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO "GET GOOD BOWING FROM THE" SECOND HYDRATOME RX AUTOTOME 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 "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583000 0011746073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK