BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR

    MDR report key: 15762435 · Received November 9, 2022

    Report

    Report Number
    3005099803-2022-06496
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 14, 2022
    Report Date
    March 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729019350
    PMA / PMN Number
    K131700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF SNARE LOOP BREAK. BLOCK H10: INVESTIGATION RESULTS A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED ONE SIDE OF THE LOOP DETACHED AND CRIMP MARKS WERE LOCATED IN THE CORRECT POSITION. NO OTHER PROBLEMS WERE NOTED. THE REPORTED COMPLAINT OF LOOP BREAK WAS CONFIRMED SINCE THE LOOP WAS DETACHED ON ONE SIDE. AN INVESTIGATION TO ADDRESS THIS PROBLEM IS IN PROGRESS. BASED ON THE ANALYSIS OF THE RETURNED DEVICE AND THE INFORMATION AVAILABLE, THE MOST PROBABLE CAUSE IS MANUFACTURING DEFICIENCY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS PREPARED TO REMOVE SIGMOID PEDICLED POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN OPENING THE PACKAGE AND TESTING THE DEVICE IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL STIFF SNARE WAS PREPARED TO REMOVE SIGMOID PEDICLED POLYP DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN OPENING THE PACKAGE AND TESTING THE DEVICE IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2948076 CAPTIVATOR SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00562341 0027210830 08714729019350

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female