BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005099803-2019-06130

    MDR report key: 9485065 · Received December 17, 2019

    Report

    Report Number
    3005099803-2019-06130
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    August 1, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE REPORTED DATE OF AUGUST 2019. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE BRAND NAME, UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOSTON SCIENTIFIC COLONIC BIOPSY FORCEPS WAS USED DURING AN OESOPHAGO-GASTRODUODENOSCOPY (OGD) PROCEDURE PERFORMED IN (B)(6) 2019. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT EXPERIENCED UPPER GASTROINTESTINAL BLEEDING AND PRESENTED TO THE EMERGENCY DEPARTMENT. THE PATIENT HAD A SYSTOLIC BLOOD PRESSURE OF 60 AND HAD THREE MORE EPISODES OF HEMATEMESIS. THE PATIENT WAS GIVEN INTRAVENOUS (IV) TRANEXAMIC ACID, IV OMEPRAZOLE, AND IV TERLIPRESSIN AND RECEIVED 4 UNITS OF BLOOD, 4 UNITS OF FRESH FROZEN PLASMA (FFP), AND 1 UNIT OF PLATELETS. AN URGENT OGD PROCEDURE WAS PERFORMED AND IT WAS NOTED THAT THE BIOPSY SITE WAS BLEEDING. THE SITE WAS TREATED WITH CAUTERY, ADRENALINE, AND 3 CLIPS. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND WAS INTUBATED. THE PATIENT IMPROVED, WAS MOVED TO THE MEDICAL WARD AND WAS DEEMED FIT FOR DISCHARGE 3 DAYS AFTER BEING ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272201 FCL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R