BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION SHORT THROW

    MDR report key: 17208972 · Received June 27, 2023

    Report

    Report Number
    3005099803-2023-03477
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729748069
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK E1: (INITIAL REPORTER EMAIL) (B)(6). BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE MAJOR. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. 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 SENSATION LARGE OVAL MED STIFF SNARE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING A GASTROSCOPY PROCEDURE, A GASTROENTEROLOGIST PERFORMED A MACRO BIOPSY IN THE GASTRIC FUNDUS AREA. A 30 MM POLYPECTOMY SNARE WAS USED FOR THE BIOPSY. THE SNARE WAS TESTED, AND IT OPENED AND CLOSED OK. AFTER CLOSING THE SNARE, THE HANDLE OF THE DEVICE DETACHED FROM THE DEVICE'S BODY. THE SNARE WAS UNABLE TO CUT. BLEEDING STARTED, AND A HEMOSTATIC MANEUVER WAS PERFORMED. IT WAS NOT REPORTED WHAT INTERVENTION WAS REQUIRED. THE PATIENT HAD TO RETURN THE NEXT DAY AND WAS TAKEN TO THE OPERATING ROOM TO UNDERGO ANOTHER HEMOSTATIC MANEUVER. IT WAS NOT REPORTED WHAT INTERVENTION WAS REQUIRED. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453203 SENSATION SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00562650 0030019397 08714729748069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R