BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1182312 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04941
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS COULD NOT BE PERFORMED DUE TO THE DEVICE NOT BEING RETURNED; CUSTOMER HAS DISPOSED THE DEVICE. DURING MANUFACTURING, THE TOME DEVICE IS 100% INSPECTED FOR TIP INTEGRITY AND ANY DEFECT IS SCRAPPED AND DOCUMENTED IN THE DEVICE HISTORY RECORD (DHR). A DHR REVIEW OF THE LOT WAS PERFORMED AND REVEALED 3 DEVICES WERE SCRAPPED FROM THE LOT FOR SPLIT TIPS. BASED ON THE EVALUATION OF OTHER DEVICES WITH THE SAME COMPLAINT (SPLIT/CRACKED TIP), THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE SINCE THIS COULD BE DUE TO USER HANDLING, CAUSED BY OTHER DEVICE OR MANUFACTURING, AND CANNOT BE DETERMINED WITHOUT EVALUATING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE HYDRATOME RX SPHINCTEROTOME TIP CRACKED. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A HYDRATOME RX SPHINCTEROTOME HAD BEEN ADVANCED THROUGH THE UNSPECIFIED TYPE OF SCOPE WHEN THE TIP CRACKED. A SECOND HYDRATOME RX SPHINCTEROTOME WAS ADVANCED, BUT UNABLE TO BE USED TO PERFORM THE SPHINCTEROTOMY AS THE CUT WIRE WAS NOT BOWING OR BENDING. A THIRD HYDRATOME RX SPHINCTEROTOME WAS SUCCESSFULLY USED IN THE PROCEDURE. AN RX LITHOTRIPTER BASKET WAS THEN ADVANCED AND SUCCESSFULLY USED "MULTIPLE" TIMES BEFORE THE BASKET FAILED TO OPEN PROPERLY AND BECAME STUCK IN THE CATHETER. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER RX LITHOTRIPTER BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED; HOWEVER, THE PATIENT'S CURRENT CONDITION IS UNKNOWN. NOTE: PLEASE REFER TO MFR #3005099803-2008-04940 THE REPORT ON THE OTHER TOME DEVICE AND MFR #3005099803-2008-04935 FOR THE REPORT ON THE BASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11926667

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK