BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 8959139 · Received September 4, 2019

    Report

    Report Number
    3002808486-2019-01394
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    July 15, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IMMEDIATE HAEMOPTYSIS WAS NOTED AFTER FROVA INTUBATION IN A PATIENT WITH SARCOIDOSIS. BLEEDING RESOLVED AFTER 15 MIN TREATMENT WITH ICED SALINE LAVAGE AND THE APPLICATION OF TOPICAL EPINEPHRINE ON THE BLEEDING LESIONS AND PATIENT WAS EXTUBATED 2 HOURS LATER. NO PRODUCT WAS RETURNED AND BASED ON THE ARTICLE AND THE IMAGE THERE THE EXACT REASON FOR THE IMMEDIATE HAEMOPTYSIS AFTER THE INTUBATION WITH THE FROVA DEVICE CANNOT BE DETERMINED. HOWEVER, IT IS REPORTED THAT THE HAEMOPTYSIS WAS NOTICED AFTER THE FROVA DEVICE REACHED THE ¿NORMAL HOLD UP¿, WHICH WAS WHERE THE ¿MULTIPLE ENDOBRONCHIAL SARCOID LESIONS¿ WERE PLACED ACCORDING TO THE SCHEMATIC DIAGRAM AND THE BRONCHOSCOPIC VIEW. CONSEQUENTLY, IT CANNOT BE EXCLUDED THAT THE FROVA DEVICE CAUSED TRAUMA TO THE SARCOID LESIONS, BUT VIDEO-ASSISTED INTUBATION COULD HAVE BEEN CONSIDERED, IF THE LESIONS WERE KNOWN PRIOR TO THE INTUBATION. THE INSTRUCTIONS FOR USE WARN THAT CARE MUST BE TAKEN NOT TO PROVOKE INJURY TO THE EPIGLOTTIS AND GLOTTIS, PERFORATION OF THE SINUS PYRIFORMIS, TRACHEA OR BRONCHUS. IT IS NOTED THAT THE BLEEDING HAD RESOLVED AFTER 15 MINUTES AND THAT THE PATIENT WAS EXTUBATED TWO HOURS LATER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS, BUT COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND / OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    BASED ON ARTICLE: "MASSIVE HAEMOPTYSIS FROM A BOUGIE INTUBATING CATHETER IN A PATIENT WITH ENDOBRONCHIAL SARCOID", ALTER ET AL 2016". (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK FROVA AIRWAY INTUBATING DEVICE. INITIAL REPORTER OCCUPATION: ASSOCIATE PROFESSOR. DEVICE UNDER 510(K)/PMA: K161813. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: TO FACILITATE TRACHEAL INTUBATION, A LUBRICATED SINGLE-USE BOUGIE INTUBATING CATHETER (FROVA, COOK MEDICAL, (B)(4)) WAS INSERTED DIRECTLY INTO THE TRACHEA AND THEN USED AS A GUIDE OVER A SIZE 7.5 FLEXIBLE NERVE MONITORING ENDOTRACHEAL TUBE (ETT) (NIM FLEX EMG ETT, BY OTHER MEDICAL DEVICE COMPANY), WHICH WAS RAILROADED. AS THE BOUGIE WAS INSERTED, NORMAL ¿CLICKS¿ WERE FELT AS THE TIP WAS ADVANCED OVER THE TRACHEAL RINGS, AND A NORMAL ¿HOLD UP¿ WAS NOTED AT 30¿40 CM DEPTH. THE ETT WAS SECURED, CUFF INFLATED AND THE BOUGIE REMOVED. IMMEDIATELY, BLOOD WAS NOTED TO FILL THE ENTIRE ETT FILTER AND ANAESTHESIA CIRCUIT. WHILE INTERMITTENTLY VENTILATING THE PATIENT WITH 100% OXYGEN (TIDAL VOLUME 500 ML, POSITIVE END EXPIRATORY PRESSURE 10 CM H2O), 950 ML BRIGHT RED BLOOD WAS SUCTIONED FROM THE ETT THROUGH A 16 G SUCTION CATHETER. FLEXIBLE BRONCHOSCOPY REVEALED MULTIPLE ENDOBRONCHIAL SARCOID LESIONS AS THE SOURCE OF BLEEDING. ICED SALINE LAVAGE AND THE APPLICATION OF TOPICAL EPINEPHRINE (5 ML 1:10 000) WERE CARRIED OUT ON THE BLEEDING LESIONS VIA A SIDE CHANNEL OF THE BRONCHOSCOPE, AND AFTER 15 MIN THE BLEEDING RESOLVED. SURGERY WAS ABANDONED AND THE PATIENT TRANSFERRED TO THE INTENSIVE CARE UNIT WITH THE ETT IN SITU. THERE WAS NO FURTHER BLEEDING AND THE PATIENT¿S TRACHEA WAS SUCCESSFULLY EXTUBATED 2 HOURS LATER. PATIENT OUTCOME: THERE WAS DIRECT TRAUMA FROM AN INTUBATING CATHETER TO BRONCHIAL LESIONS RESULTING IN MASSIVE HAEMOPTYSIS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752878 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R