BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9449298 · Received December 11, 2019

    Report

    Report Number
    3002808486-2019-01951
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 26, 2019
    Report Date
    June 9, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002236462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# PR286515 SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON EVENT DESCRIPTION AND ANALYSIS OF THE RETURNED DEVICE. IT WAS REPORTED THAT AFTER PLACEMENT OF A SINGLE LUMEN TUBE AN OBJECT DEEMED TO BE PART OF THE FROVA WAS SEEN IN THE AIRWAYS. THE PART WAS REMOVED FROM THE BRONCHUS WITH NO REPORTED HARM TO THE PATIENT. A USED FROVA INTRODUCER WAS RETURNED WITH THE STYLET INSIDE AND WITH A SMALL 5.5MM CURLY PIECE OF THE FROVA AS REPORTED. DURING INVESTIGATION TWO SHAVINGS WERE NOTED ON THE FROVA - ONE PIECE 50MM LONG AT THE PROXIMAL END - ONE PIECE 10MM LONG CLOSE TO A SIDE HOLE IMMEDIATELY, THE EXACT REASON FOR THE SHAVINGS CANNOT BE DETERMINED. REPORTEDLY THE INTRODUCER WAS USED FOR PLACEMENT OF A SINGLE LUMEN TUBE, BUT THERE IS NO INFORMATION PROVIDED CONCERNING THE TUBE ITSELF OR ITS INNER DIAMETER. ACCORDING TO THE INSTRUCTIONS FOR USE THE FROVA DEVICE IS INTENDED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6MM OR LARGER AND ALSO, THE IFU WARN THAT THE CATHETER INTRODUCER AND THE ENDOTRACHEAL TUBE MUST BE LUBRICATED BEFORE USE. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO EVIDENCE TO SUGGEST THAT THE DEVICE 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMTION RECEIVED 11DEC2019: IT WAS A SINGLE LUMEN TUBE AT THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). PMA/510(K) K161813. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT WAS INTUBATED WITH THE FROVA INTRODUCER WHICH WAS THEN REMOVED. DURING A CHECK OF THE AIRWAYS, AN OBJECT WAS SEEN AND ONCE REMOVED IT WAS DEEMED TO BE PART OF THE INTRODUCER. THEY CALLED THE PULMONOLOGY TO REMOVE THE PIECE OF DEVICE REMAINED IN THE MAIN BRONCHUS. PATIENT OUTCOME: THE SMALL PIECE HAS BEEN REMOVED, WITHOUT ANY INCONVENIENCE. 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
    1247214 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE G23646 E3528140 00827002236462

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening