BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW 4

    MDR report key: 8615694 · Received May 16, 2019

    Report

    Report Number
    3005099803-2019-02533
    Event Type
    Death
    Date Received
    May 16, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    UDI-DI
    08714729792864
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. 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 RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN A BRONCHOSCOPY PROCEDURE WITH LUNG MASS BIOPSY PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BIOPSIES WERE TAKEN UNDER FLUOROSCOPY. ON THE THIRD BIOPSY, THE PATIENT BEGAN TO BLEED. THERE WAS NO ALLEGED MALFUNCTION OR DEFICIENCY OF THE RADIAL JAW 4 FORCEPS. TO CONTROL THE BLEEDING, EPINEPHRINE WAS INJECTED AND COLD SALINE WAS FLUSHED THROUGH THE BRONCHOSCOPE. DUE TO DECREASED SATURATION LEVELS, THE SCOPE WAS THEN REMOVED FROM THE PATIENT, AND AN AMBU BAG WAS USED. SATURATION LEVELS CONTINUED TO DROP, AND A CODE BLUE WAS CALLED. THE PATIENT WAS THEN INTUBATED, AND THE SCOPE WAS REINTRODUCED INTO THE PATIENT. UPON RE-BRONCHOSCOPY, A LARGE SADDLE-MASS WAS VISUALIZED OVERLYING THE MAIN CARINA OCCLUDING BOTH MAIN STEMS AND THE DISTAL END OF THE ET TUBE. NUMEROUS CLOTS WERE THEN REMOVED USING A TRAPEZOID BASKET AND RADIAL JAW 4 HOT FORCEPS, THOUGH THE LARGE MASS WAS NOT ABLE TO BE EXTRACTED. THE BLEEDING HAD SUBSIDED BY THIS POINT, AND IT WAS NOTED THAT THE LARGE CLOT REMAINED AS THE "INCITING CULPRIT". THE PATIENT CODED AGAIN. COLD SALINE WAS FLUSHED AGAIN, WITH 3 ROUNDS OF ATROPINE BEING ADMINISTERED EVERY 30 MINUTES AND CHEST COMPRESSIONS BEING ADMINISTERED THROUGHOUT. THE PATIENT WAS THEN MOVED TO THE CORONARY CARE UNIT (CCU) ON VENTILATOR AND EXPIRED SHORTLY AFTER AT APPROXIMATELY 12:00PM. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT'S CAUSE OF DEATH WAS HYPOXIC ARREST. ACCORDING TO THE PHYSICIAN, THERE WAS NO RELATIONSHIP BETWEEN THE RADIAL JAW 4 PULMONARY FORCEPS AND THE PATIENT'S DEATH OTHER THAN "IT WAS USED AND BLEEDING WAS CAUSED" AND THAT THE PATIENT'S DEATH WAS ATTRIBUTABLE TO THE OBSTRUCTION CAUSED BY THE SADDLE-MASS OVERLYING THE MAIN CARINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410168 RADIAL JAW 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC CORPORATION M00515181 08714729792864

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death