BEUDAMED
    FDA Adverse Event Death Summary report: N

    EARLY BIRD BLEED MONITORING SYSTEM

    MDR report key: 16441207 · Received February 26, 2023

    Report

    Report Number
    3016011241-2023-00001
    Event Type
    Death
    Date Received
    February 26, 2023
    Date of Event
    June 16, 2020
    Report Date
    January 19, 2023
    Manufacturer
    SARANAS, INC.
    Product Code
    QFJ
    UDI-DI
    00866532000402
    PMA / PMN Number
    DEN180021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION AND DATA COLLECTED, IT WAS DETERMINED THAT THE EBBMS DID NOT CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY OR ILLNESS FOR THIS EVENT. THE EBBMS DEVICE FUNCTIONED AS INTENDED AS EVIDENCED IN THE DATA SHOWING THE EBBMS TRIGGERED AFTER DEVICE ACTIVATION INDICATING AN INTERNAL BLEED COMPLICATION. RELATED REPORT NUMBER: 3016011241-2022-00001.

    Description of Event or Problem · 0

    DURING THE LARGE-BORE 16F SHEATH REMOVAL AND WIRE EXCHANGE, THE FIRST EARLY BIRD LEVEL 1 INDICATION WAS TRIGGERED. SHORTLY THEREAFTER, THE PATIENT'S PRESSURE DROPPED SIGNIFICANTLY, AND IT WAS DETERMINED AT THAT TIME THAT THE PATIENTS RIGHT COMMON ILIAC WAS PERFORATED. DR. (B)(6) AND STAFF BEGAN APPLYING PRESSURE WHILE THEY ASSESSED. DR. (B)(6) THEN PLACED 3 ATRIUM ILIAC COVERED STENTS TO REPAIR THE RIGHT COMMON ILIAC; THIS TOOK ROUGHLY 8-10 MINUTES. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE ILIAC STENT PLACEMENT AND ASSESS THE SITUATION. UNDER FURTHER EXAMINATION, IT WAS DETERMINED THAT THERE WAS ANOTHER PERFORATION NEAR THE AORTIC BIFURCATION. AN AORTIC OCCLUSION BALLOON (24 MM TRUE BALLOON) WAS PLACED IN THE ABDOMINAL AORTA TO TRY AND STOP THE BLEEDING. DURING THIS TIME, CPR AND CHEST COMPRESSIONS WERE BEING PERFORMED. ROUGHLY 18 MINUTES AFTER THE EARLY BIRD INDICATION, THE PATIENT HAD EXPIRED. THE EARLY BIRD WAS RETRIEVED AND SHIPPED BACK TO SARANAS FOR SIGNAL EXAMINATION. SARANAS CHIEF MEDICAL OFFICER THEN DISCUSSED THE BLEEDING SIGNAL WITH DR. (B)(6). PATIENT INFORMATION WAS NOT MADE AVAILABLE TO SARANAS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947396 EARLY BIRD BLEED MONITORING SYSTEM INTRAVASCULAR BLEED MONITOR QFJ SARANAS, INC. FG001-01 503109G 00866532000402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| C| R| D 24 MM TRUE BALLOON| LARGE-BORE 16F EDWARDS SHEATH