BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME SPHINCTEROTOME

    MDR report key: 969060 · Received December 26, 2007

    Report

    Report Number
    6000048-2007-00347
    Event Type
    Malfunction
    Date Received
    December 26, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 28, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISCARDED BY THE USER FACILITY; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. THE LOT NUMBER IS UNK. A CUSTOMER SHIPMENT HISTORY REVIEW REVEALED THREE LOTS (8973265, 11045471, AND 9795676) THAT WERE SHIPPED TO THE CUSTOMER PRIOR TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THESE LOTS REVEALED NO ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOR LOT NUMBERS 11045471 AND 9795676 DID NOT IDENTIFY ANY ADD'L COMPLAINTS RECORDED FOR THE SAME LOTS. HOWEVER, THE LOT HISTORY SEARCH FOR LOT NUMBER 8973265 DID IDENTIFY TWO SIMILAR COMPLAINTS AGAINST THIS LOT (ONE FOR BENT WORKING LENGTH AND ONE FOR SPLINTERED/FRAYED TIP). THE NOV 2007 15-MONTH JAGTOME SPHINCTEROTOME PROD FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THE HYDRATOME SPHINCTEROTOME PROD FAMILY IS INCLUDED IN THE SAME TREND REPORT AS THE JAGTOME PROD FAMILY SINCE BOTH FAMILIES UTILIZE THE SAME SPHINCTEROTOME DEVICE.

    Description of Event or Problem · 1

    A HYDRATOME SPHINCTEROTOME WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGEOPANCREATOGRAPHY (ERCP) PROCEDURE, ON A MALE PT, (WEIGHT UNK), IN 2007. ALTHOUGH THE PT'S ACTUAL AGE IS UNK. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE CUT WIRE BROKE." THE PHYSICIAN REMOVED THE BROKEN DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER HYDRATOME SPHINCTEROTOME. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORP. M00583060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR