BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 12638050 · Received October 15, 2021

    Report

    Report Number
    3002808486-2021-01864
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    June 25, 2021
    Report Date
    January 31, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002483033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: SHAVINGS OF BLUE PLASTIC, LIKELY FROM FROVA DEVICE, WERE FOUND IN THE PATIENT¿S BRONCHUS. REMOVED BY BRONCHOSCOPE WITHOUT ANY NOTED INJURIES TO THE PATIENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION AND WITHOUT THE ACTUAL COMPLAINT DEVICE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE SHAVINGS. 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." THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. REPORTER OCCUPATION: SAFETY OFFICER. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K161813. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: SHAVINGS OF BLUE PLASTIC FOUND IN THE PATIENTS BRONCHUS, WHEN PERFORMING BRONCHOSCOPY. ORIGINS OF PLASTIC FRAGMENTS UNCLEAR, SUSPICIOUS THAT IT MIGHT ORIGINATE FROM BLUE COOK BOUGIE - CATHETER. WE TURNED THE PATIENT INTO THE LATERAL POSITION FOR THE SECOND STAGE PART OF THE CASE. DURING THIS PROCESS OF CHECKING THE POSITION OF THE DOUBLE LUMEN TUBE, A BLUE OBJECT COULD BE SEEN IN THE RIGHT LOWER LOBE BRONCHUS. SURGICAL TEAM WERE INFORMED AND VIEWED THE OBJECT VIA THE SCOPE. SURGICAL TEAM AND ANESTHETIC TEAM DISCUSSED THIS WITH THE THORACIC SURGEON. THE DECISION WAS MADE TO REMOVE AND RETRIEVE THE FOREIGN OBJECT VIA A BRONCHOSCOPY. THORACIC SURGEON CHECKED THE LEFT LOBE AND MORE PLASTIC WAS RETRIEVED. 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
    1540416 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE G48303 E4061374 00827002483033

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention