BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9590157 · Received January 15, 2020

    Report

    Report Number
    3002808486-2020-00031
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 23, 2019
    Report Date
    July 27, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON THE EVENT DESCRIPTION ONLY. IT WAS REPORTED THAT AFTER PLACEMENT OF A DOUBLE LUMEN TUBE A SMALL FOREIGN BODY FRAGMENT DETERMINED TO BE FROVA MATERIAL WAS OBSERVED IN THE PATIENT. THE FRAGMENT WAS EXTRACTED BY USE OF RIGID BRONCHOSCOPE AND ENDOSCOPIC TWEEZERS. THE FROVA DEVICE NOR THE SMALL FRAGMENT WAS RETURNED FOR INVESTIGATION AND THEREFORE THE EXACT REASON FOR THE FRACTURE CANNOT BE DETERMINED. HOWEVER, IT IS NOTED THAT THE INTRODUCER WAS USED FOR PLACEMENT OF A DOUBLE LUMEN TUBE AND ACCORDING TO THE INSTRUCTIONS FOR USE THE FROVA INTRODUCER HAS BEEN DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6MM OR LARGER. THEREFORE, THE USE OF THE DLT IS CONSIDERED THE LIKELY CAUSE OF THIS OCCURRENCE. IFU, INTENDED USE: "THE 14.0 FRENCH CATHETER INTRODUCER HAS BEEN DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6 MM OR LARGER.". NOTE: "DO NOT USE THE FROVA INTUBATING INTRODUCER WITH DOUBLE LUMEN ENDOTRACHEAL OR ENDOBRONCHIAL TUBES.". WARNINGS: "DO NOT USE THE FROVA INTUBATING INTRODUCER WITH DOUBLE LUMEN ENDOTRACHEAL OR ENDOBRONCHIAL TUBES.". NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING 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

    (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K) K161813. INVESTIGATION IS STILL IN PROGRESS

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PLACEMENT OF DOUBLE LUMEN TUBE WITH COOK FROVA CATHETER ON THE LEFT BRONCHUS. UNDER FIBROSCOPIC VISION, A FOREIGN BODY FRAGMENT IS OBSERVED. RIGID BRONCHOSCOPE AND ENDOSCOPIC TWEEZERS WERE USED TO EXTRACT THE FOREIGN BODY FRAGMENT. AFTER THAT THEY CHECK THE FRAGMENT AND THEY DETERMINATED THAT THE FRAGMENT IS FROVA MATERIAL. PATIENT OUTCOME. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54670 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R