BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR II POLYPECTOMY SNARE

    MDR report key: 1052633 · Received May 27, 2008

    Report

    Report Number
    3005099803-2008-00552
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED; NO ANOMALIES WERE NOTED RELATED TO THIS EVENT. A SEARCH OF THE COMPLAINT DATABASE IDENTIFIED ONE ADDITIONAL COMPLAINT REPORTED FOR THIS LOT (SAME CUSTOMER, SAME EVENT). THE APRIL 2008 15-MONTH CAPTIVATOR SNARES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A CAPTIVATOR II POLYPECTOMY SHARE DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, ".. AFTER THE SNARE WAS USED TO REMOVE A POLYP, THE PT DEVELOPED A BLEED. THE PHYSICIAN USED CLIPS AND INJECTIONS [TO STOP THE BLEEDING]." NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PT'S CONDITION WAS REPORTED AS "STABLE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIVATOR II POLYPECTOMY SNARE FDI BOSTON SCIENTIFIC CORPORATION M00561291 0011333813

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R