BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATABLE SNARE

    MDR report key: 1000421 · Received February 22, 2008

    Report

    Report Number
    3005099803-2008-00192
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE DECEMBER 2007 15-MONTH ROTATABLE SNARES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A ROTATABLE SNARE WAS USED DURING A POLYPECTOMY ON A MALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, AFTER "A LARGE POLYP WAS REMOVED WITH THIS ROTATABLE SNARE..A SMALL BLEEDING APPEARED". THE TIP OF THE SNARE WAS USED TO COAGULATE THE BLEEDING. REPORTEDLY, AFTER THE COAGULATION, IT WAS DISCOVERED THAT "THE WIRE PARTLY DETACHED FROM [THE TIP OF] THE LOOP." AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE SNARE FDI BOSTON SCIENTIFIC CORPORATION M00561831 11211383

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention