BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1213841 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05421
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE MFR DATE CANNOT BE DETERMINED. THE LOT NUMBER OF THE DEVICE IN QUESTION WAS UNABLE TO BE PROVIDED. THE SUBJECT DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS AS IT WAS DISPOSED OF BY THE USER FACILITY. BASED ON EVAL OF OTHER SIMILAR DEVICE WITH THE SAME ISSUE OF A TORN AND/OR SPLIT TIP, THE MOST PROBABLE ROOT CAUSE IS RELATED TO HANDLING DAMAGE DURING THE REMOVAL OF METAL MANDREL FROM THE DISTAL TIP DURING UNPACKING OF THE DEVICE. DURING MFG, THE TOME DEVICES ARE 100% INSPECTED FOR TIP INTEGRITY.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT FAILED DURING PREPARATION PRIOR TO THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC DURING PREPARATION PRIOR TO AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) OF THE COMMON BILE DUCT, THE SPHINCTEROTOME'S TAPERED TIP WAS NOTED TO BE TORN AS THE DEVICE WAS REMOVED FROM THE PACKAGING. ANOTHER SIMILAR SPHINCTEROTOME WAS REMOVED FROM ITS PACKAGING AND THE SAME ISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH THE USE OF A THIRD SPHINCTEROTOME. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PT WAS REPORTED AS "OK" FOLLOWING THE PROCEDURE. REFER TO ASSOCIATED MFR REPORT # 3005099803-2008-05422 FOR A DESCRIPTION OF THE FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545170 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK