BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 8959001 · Received September 4, 2019

    Report

    Report Number
    3002808486-2019-01393
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    October 1, 2016
    Report Date
    June 10, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# PR273801 SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON THE EVENT DESCRIPTION ONLY. FROM A PUBLICATION REVIEW COOK MEDICAL BECAME AWARE OF A LITERATURE ARTICLE "IS IT SAFE TO USE FROVA AIRWAY INTUBATING DEVICE DURING TRACHEAL INTUBATION IN DIFFICULT AIRWAY PATIENT WITH MULTIPLE AND CHEST TRAUMA?" A FEMALE PATIENT INVOLVED IN A MVA PRESENTED WITH NORMAL VITAL SIGNS, BUT AFTER 10 MINUTES THE LEVEL OF CONSCIOUSNESS DETERIORATED AND THE 02 SATURATION DROPPED. IT TAKES 3 ATTEMPTS TO INTUBATE WITH THE FROVA AIRWAY INTUBATING INTRODUCER WITH STIFFENING CANNULA. IMMEDIATELY AFTER THE INTUBATION THE PATIENT DEVELOPED BILATERAL SUBCUTANEOUS EMPHYSEMA AND SEVERE HYPOXIA. A CHEST CT-SCAN, AFTER THE INTUBATION SHOWED AN ALMOST COMPLETE TEAR OF THE RIGHT MAIN BRONCHUS NEAR THE CARINA, FURTHER WAS NOTICED AND A 4 CM LONG LACERATION WAS NOTED IN THE DISTAL TRACHEA. NO IMAGING WAS PROVIDED AND THEREFORE IT WOULD BE INAPPROPRIATE TO SPECULATE, IF THE FROVA DEVICE DID TEAR THE RIGHT MAIN BRONCHUS MORE APART, BUT IT IS SEEMS UNLIKELY, THAT THE FROVA DEVICE ITSELF MAY HAVE CAUSED A "NEAR COMPLETE TEAR" OF THE RIGHT MAIN BRONCHUS. HOWEVER, AS THE PATIENT REPORTEDLY WAS INTUBATED DUE TO A SUDDEN DESATURATION, IT SEEMS LIKELY THAT THERE WAS AN INJURY IN THE TRACHEA 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 PATIENT WAS DISCHARGED AT DAY 20 WITH NO SEQUALAE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. 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: "IS IT SAFE TO USE FROVA AIRWAY INTUBATING DEVICE DURING TRACHEAL INTUBATION IN DIFFICULT AIRWAY PATIENT WITH MULTIPLE AND CHEST TRAUMA? HAJJAR ET AL. 2016" MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK FROVA AIRWAY INTUBATING DEVICE. DEVICE UNDER 510(K)/PMA: K161813. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: ON ARRIVAL TO THE ER HER VITAL SIGNS WERE NORMAL INCLUDING O2 SATURATION 100% ON FACEMASK OF FULL FLOW OF O2; 10 MIN LATER, HER LEVEL OF CONSCIOUSNESS STARTED TO DETERIORATE AND O2 SATURATION DROPPED, WHICH REQUIRED SECURING THE AIRWAY AND VENTILATION, AND INTUBATION TRIAL WAS ATTEMPTED TWICE BUT FAILED. ON THE 3RD TIME, FROVA AIRWAY INTUBATING INTRODUCER (FAII) (COOK) WITH ITS METALLIC STIFFENING CANNULA WAS USED AND INSERTED INTO THE AIRWAY AND THEN TRACHEAL TUBE SLIDED OVER FAII, WHICH WAS REPORTED AS SUCCESSFUL INTUBATION. IMMEDIATELY AFTER INTUBATION, THE PATIENT STARTED TO HAVE EXTENSIVE BILATERAL SUBCUTANEOUS EMPHYSEMA AND SEVERE HYPOXIA. CHEST X-RAY SHOWED EXTENSIVE SURGICAL EMPHYSEMA AND RIGHT SIDE TENSION PNEUMOTHORAX, WHICH WAS NOT RELIEVED BY BILATERAL CHEST TUBE INSERTION. FURTHER, THERE WAS MASSIVE AIR LEAK FROM THE RIGHT CHEST TUBE WHICH REQUIRED THE SECOND CHEST TUBE TO BE INSERTED, AFTER WHICH THE PATIENT O2 SATURATION IMPROVED TEMPORARILY; WHICH ALLOWED FOR CT SCAN CHEST, WHICH SHOWED NEAR COMPLETE TEAR OF THE ORIGIN OF THE RIGHT MAIN BRONCHUS. THERE WAS ALSO A SIGNIFICANT AMOUNT OF SURGICAL EMPHYSEMA DISPERSING INTO THE MEDIASTINUM AND THE PLEURAL SPACES CAUSING PNEUMOTHORAX AND SOFT-TISSUE EMPHYSEMA. FIBEROPTIC BRONCHOSCOPY (FOB) PERFORMED IN ER WHICH SHOWED A COMPLETE TRANSECTION OF THE RIGHT MAIN BRONCHUS AT THE ORIGIN FROM THE CARINA, AND ALSO, THERE WAS A LACERATION 4 CM IN LENGTH ON THE RIGHT SIDE OF THE LOWER TRACHEA. PATIENT OUTCOME: THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. IMMEDIATELY, THE PATIENT TRANSFERRED TO THE OPERATING ROOM (OR); THE TRACHEAL TUBE WAS DIRECTED TO THE LEFT MAIN BRONCHUS GUIDED BY FOB FOR LUNG ISOLATION, VENTILATION, AND BETTER VISUALIZATION. RIGHT THORACOTOMY PERFORMED, AND EXPLORATION SHOWED THAT THE MEDIASTINAL PLEURA WAS INTACT AND NOT INJURED BUT THERE WAS UNDERNEATH IT COMPLETE TRANSACTION OR AVULSION OF THE RIGHT MAIN BRONCHUS FROM THE CARINAL ORIGIN, WHICH EXTENDS 4 CM UPWARD TO THE LOWER TRACHEA. COMPLETE AND DIRECT REPAIR OF BOTH THE RIGHT MAIN BRONCHUS AND THE TRACHEAL LACERATION WERE PERFORMED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. BILATERAL SUBCUTANEOUS EMPHYSEMA, HYPOXIA, PNEUMOTHORAX, NEAR COMPLETE TEAR OF THE ORIGIN OF THE RIGHT MAIN BRONCHUS AND 4 CM LACERATION OF TRACHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752755 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| R