BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9887457 · Received March 27, 2020

    Report

    Report Number
    3002808486-2020-00368
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    March 20, 2020
    Report Date
    July 27, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 BLUE PARTS OF THE FROVA REMAINED IN THE PATIENT, BUT WERE EASILY REMOVED BY SUCTION. THE FROVA DEVICE NOR THE SMALL FRAGMENT WAS RETURNED FOR INVESTIGATION AND THEREFORE THE EXACT REASON FOR THE FLAKING OFF 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

    MANUFACTURER REF# (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: THEY WANTED TO PLACE A DOUBLE LUMEN TUBE WITH THE FROVA AND AFTER PROCEDURE THEY FOUND THAT BLUE PARTS OF THE FROVA REMAINED IN THE PATIENT BUT DOCTOR COULD RETRIEVE ALL. AT THE END OF A RIGID BRONCHOSCOPY RE-INTUBATION WITH FROVA. AFTERWARDS A DOUBLE LUMEN TUBE WAS PLACED OVER THE FROVA. AT CONTROL AFTER FINAL POSITIONING OF THE PATIENT, 3 SMALL RUBBER PARTS WERE OBSERVED AT THE TRANSITION FROM DOUBLE LUMEN TUBE TO LEFT BRONCHUS. EASY REMOVAL OF THE FEMORAL BODY BY SUCTION. PATIENT OUTCOME: NO INJURY TO PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352417 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention