BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION SHORT THROW

    MDR report key: 17957022 · Received October 18, 2023

    Report

    Report Number
    3005099803-2023-05531
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 27, 2023
    Report Date
    November 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729283904
    PMA / PMN Number
    K131700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF UNABLE TO CUT BLOCK H10 INVESTIGATION RESULTS: ONE SENSATION SNARE WAS RECEIVED FOR ANALYSIS. VISUAL AND ELECTRICAL ANALYSIS OF THE RETURNED DEVICE FOUND NO DEVICE PROBLEMS. NO OTHER PROBLEMS WERE NOTED. THE REPORTED EVENTS OF "LOOP FAILURE TO CUT" COULD NOT BE CONFIRMED SINCE COULD NOT BE CONFIRMED SINCE THE DEVICE CANNOT BE FUNCTIONALLY EVALUATED WITH RESPECT TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THE PRODUCT RECORD REVIEW CONFIRMED THAT THIS WAS NOT A NEW FAILURE TYPE AND THE RISK WAS ANTICIPATED. THERE WAS NO EVIDENCE OF A MANUFACTURING PROBLEM, DESIGN OR USER PROBLEM WHICH COULD HAVE CAUSED THE COMPLAINT. DEVICE ANALYSIS FOUND NO PROBLEMS WITH THE DEVICE DURING VISUAL AND ELECTRICAL TEST. BASED ON THE ANALYSIS OF THE RETURNED DEVICE AND THE INFORMATION AVAILABLE, THE CODE SELECTED AS THE MOST PROBABLE ROOT CAUSE IS NO PROBLEM DETECTED. THIS CODE WAS SELECTED SINCE THE REPORTED EVENT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF UNABLE TO CUT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO CUT THROUGH THE POLYP. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION MEDIUM OVAL MED STIFF SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO CUT THROUGH THE POLYP. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION MEDIUM OVAL MED STIFF SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203285 SENSATION SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00560311 0031773344 08714729283904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown