BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 830706 · Received March 26, 2007

    Report

    Report Number
    6000048-2007-00104
    Event Type
    Death
    Date Received
    March 26, 2007
    Date of Event
    February 21, 2007
    Report Date
    February 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MND
    PMA / PMN Number
    k040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUPPLIED IN SECTION F WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMAITON OBTAINED FROM THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES ASSOCIATED WITH THIS INCIDENT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND ONE OTHER UNRELATED COMPLAINT HAD BEEN REPORTED FOR A DIFFERENT FAILURE MODE (PREMATURE DEPLOYMENT IN SHEATH). IN ADDITION, THE 2007 15-MONTH COMPLAINT TREND REPORT WAS REVIEWED; AN UNFAVORABLE TREND WAS NOTED. NO DATA POINTS EXCEED THE BSC TRIGGER ACTION LIMIT. TWO CONSECUTIVE MONTHS OF INCREASING NUMBER OF COMPLAINTS IS IDENTIFIED AS AN UNFAVORABLE TREND. FIFTY FIVE COMPLAINTS FOR THIS PRODUCT FAMILY WERE REPORTED IN 2006, 61 WERE REPORTED IN 2007 AND 74 COMPLAINTS WERE REPORTED IN 2007. DUE TO THE LOW NUMBER OF INCREASED COMPLAINTS (A TOTAL INCREASE OF 19 COMPLAINTS), THE LOW MAGNITUDE OF THE NUMBER COMPLAINTS, AND THE LOW CLINICAL SEVERITY OF THE FAILURE MODES, NO SPECIFIC ACTION IS WARRANTED AT THIS TIME. PLEASE NOTE ASSOCIATED MEDWATCH REPORT 6000048-2007-00103.

    Description of Event or Problem · 1

    IN 2007, THE CUSTOMER REPORTED TO BSC THAT DURING A STENT PLACEMENT PROCEDURE ON A MALE PATIENT, THE RESOLUTION CLIP WAS BEING USED AS A PLACEMENT MARKER; HOWEVER, THE CLIP WOULD NOT ADVANCE OUT OF THE SHEATH. THIS REPORT REPRESENTS THE SECOND OF 2 DEVICES WHICH MALFUNCTIONED. THE THIRD AND FOURTH CLIP PLACEMENTS WERE SUCCESSFUL. SHORTLY AFTER THE THIRD AND FOURTH CLIPS WERE PLACED, THE PATIENT BEGAN TO VOMIT BLOOD. THE PATIENT SUBSEQUENTLY DIED (UNK TIME BETWEEN THE HEMOPTYSIS AND THE PATIENT'S EXPIRATION). ACCORDING TO THE PHYSICIAN, "THE CAUSE OF DEATH WAS DUE TO AN ESOPHAGEAL AORTIC FISTULA"; IT WAS "NOT RELATED TO THE DEVICE'S PERFORMANCE." MULTIPLE REQUEST FOR AUTOPSY RESULTS FROM THE CUSTOMER WERE TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE KOD MND BOSTON SCIENTIFIC M00522611 0ML6081804

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death