BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 10016571 · Received May 1, 2020

    Report

    Report Number
    3002808486-2020-00482
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Report Date
    May 1, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). BASED ON ARTICLE: DIFFICULT AIRWAY MANAGEMENT FROM EMERGENCY DEPARTMENT TILL INTENSIVE CARE UNIT. PRADHAN AND BRATTACHARYYA 2015. CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK FROVA INTUBATING INTRODUCER SIMILAR TO DEVICE UNDER PMA/510(K) K161813. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON THE INFORMATION PROVIDED IN THE ARTICLE ONLY. IT WAS REPORTED, THAT IT WAS NOT POSSIBLE TO DIFFERENTIATE THE STRUCTURES IN AND AROUND EPIGLOTTIS, SO INTUBATION ATTEMPT FAILED AND THE FROVA DEVICE WENT INTO THE ESOPHAGUS. IT IS NOTED THAT IT HAD NOT ADVERSE EFFECTS TO THE PATIENT AND THE PATIENT WAS SUCCESSFULLY INTUBATED WITH ANOTHER DEVICE. NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED, THEREFORE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FROVA DEVICE TO REACH THE ESOPHAGUS. THE ARTICLE DESCRIBES A WELL KNOWN RISK OCCURRENCE AT ALL TYPES OF INTUBATION. THIS IS ADDRESSED IN THE IFU UNDER WARNINGS, WHERE IT IS MENTIONED THAT A RISING CHEST-WALL, PULSE OXIMETRY AND OXYGEN AIR FLOW SHOULD BE MONITORED IN ORDER TO ENSURE CORRECT ANATOMICAL PLACEMENT. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: AFTER AN UNEVENTFUL SHIFT TO THE ICU A COOK FROVA INTUBATING INTRODUCER WAS INSERTED BLINDLY THROUGH THE PLMA. THE FIRST ATTEMPT FAILED, AND THE CATHETER WENT INTO THE ESOPHAGUS. AN ATTEMPT AT VIDEO LARYNGOSCOPY BY USING C-MAC (KARL STORZ, (B)(4)) WAS CARRIED OUT. HOWEVER WE WERE UNABLE TO DIFFERENTIATE THE STRUCTURES IN AND AROUND EPIGLOTTIS, SO AN ATTEMPT AT INSERTION UNDER C-MAC VISUALIZATION WAS MADE. THE FOLLOWING RESISTANCE IN THE FIRST ATTEMPT, CATHETER WENT INSIDE TRACHEA SUCCESSFULLY, WHICH WAS CONFIRMED BY CAPNOGRAPHY AS WELL AS CLINICALLY. OXYGENATION WAS ADEQUATE WITH STABLE HEMODYNAMICS. FINALLY, UNDER C-MAC VISUALIZATION, A 7.5 MM ENDOTRACHEAL TUBE (ETT) WAS RAILROADED AND DEFINITIVE AIRWAY WAS SUCCESSFULLY ESTABLISHED. PATIENT OUTCOME: MALPOSITIONING (ESOPHAGUS INTUBATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482497 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR