BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIMA PLUS BILIARY

    MDR report key: 20610618 · Received November 5, 2024

    Report

    Report Number
    3005099803-2024-05546
    Event Type
    Death
    Date Received
    November 5, 2024
    Date of Event
    January 1, 2015
    Report Date
    November 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B2: THE EXACT DATE OF THE PATIENTS' DEATHS WERE NOT REPORTED. THE RETROSPECTIVE STUDY DATE JANUARY 1, 2015, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 2015 AND NOVEMBER 2021. BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE JANUARY 1, 2015, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 2015 AND NOVEMBER 2021. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: CARLOS ERNESTO LAMBO-MORENO; OSCAR MAURICIO MUNOZ-VELANDIA; ANA MARIA LEGUIZAMO; DAVID LAROTTA; ROMULO VARGA. "CLINICAL CHARACTERISTICS, TREATMENTS, AND OUTCOMES OF DIFFICULT BILIARY STONES IN A REFERENCE HOSPITAL IN COLOMBIA." REV GASTROENTEROL PERU. 2023; 43(2):120-6. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE "FOUR OF THE PATIENTS REPORTEDLY DIED DURING THE FOLLOW-UP PERIOD."

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES MENTIONED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORTS # 3005099803-2024-05581 AND 3005099803-2024-05583 FOR THE ASSOCIATED DEVICE INFORMATION. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM, CRE RX BILIARY BALLOON DILATATION CATHETER AND SPYGLASS DS DIRECT VISUALIZATION SYSTEM THROUGH THE ARTICLE "CLINICAL CHARACTERISTICS, TREATMENTS, AND OUTCOMES OF DIFFICULT BILIARY STONES IN A REFERENCE HOSPITAL IN COLOMBIA" BY CARLOS ERNESTO LOMBO-MORENO, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2015 AND NOVEMBER 2021, A TOTAL OF 146 PATIENTS WITH DIFFICULT BILIARY STONES (DBS) WERE INCLUDED IN THIS STUDY. FOUR OF THE PATIENTS REPORTEDLY DIED DURING THE FOLLOW-UP PERIOD. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598986 FLEXIMA PLUS BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death