BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR

    MDR report key: 17224397 · Received June 29, 2023

    Report

    Report Number
    3005099803-2023-03357
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    March 27, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729019336
    PMA / PMN Number
    K131700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP CUTTING ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE COULD NOT BE TIGHTENED WHEN CLOSED. THE ROOT OF THE POLYP COULD NOT BE CUT FROM THE INTESTINAL WALL AND IT WAS REPORTED THAT THE WOUND SURFACE WAS LARGE. THERE WAS NO INTERVENTION REQUIRED TO ADDRESS THE BLEEDING AND THE BLEEDING RESOLVED ON ITS OWN. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR MEDIUM OVAL . THE PATIENT'S CURRENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322096 CAPTIVATOR SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00562321 0029988909 08714729019336

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female