BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9652375 · Received January 31, 2020

    Report

    Report Number
    3002808486-2020-00126
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 17, 2020
    Report Date
    May 29, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002483033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND THE RETURNED DEVICE. IT WAS REPORTED THAT A SMALL FRAGMENT OF BLUE PLASTIC WAS FOUND IN THE PATIENT DURING PLACEMENT OF A DOUBLE LUMEN TUBE. THE FRAGMENT WAS RETRIEVED USING ENDOSCOPIC GRASPER FORCEPS WITHOUT FURTHER COMPLICATIONS. THE RETURNED FROVA DEVICE WAS ANALYSED AND DENTS AND SEVERAL SHAVINGS WERE NOTED; A 16MM SHAVING 13MM FROM DISTAL TIP, A 10MM SHAVING 462MM FROM DISTAL TIP, A 16MM SHAVING 495MM FROM DISTAL TIP, AND A 30MM SHAVING 550MM FROM DISTAL TIP. THE EXACT REASON FOR THE FLAKING OFF OF THE INTRODUCER CANNOT BE DETERMINED, BUT IT IS NOTED THAT THE INTRODUCER WAS USED FOR PLACEMENT OF A DOUBLE LUMEN TUBE AND THAT DIFFICULTIES ENCOUNTERED WHEN ADVANCING THE TUBE RESULTED IN "THE TUBE HAD TO BE FORCED OVER THE BOUGIE". 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 IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE TO SUGGEST THAT THIS 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.

    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: A PATIENT REQUIRED A DOUBLE-LUMEN TUBE (ENDOBRONCHIAL TUBE) FOR A THORACOSCOPIC PROCEDURE. A SHILEY 35FR LEFT ENDOBRONCHIAL TUBE FROM ANOTHER MANUFACTURER WAS SELECTED, WHICH HAS A 12FR INSTRUMENT PORT, SUGGESTING IT SUITABLE FOR BOUGIES NO LARGER THAN 12FR. THE TEAM ENCOUNTERED DIFFICULTY ADVANCING THE TUBE, SO INTUBATED THE PATIENT WITH THE ABOVE 14FR BOUGIE AND ATTEMPTED TO PASS THE TUBE OVER THE BOUGIE. THE BOUGIE GOT STUCK AT 31 CM, AND THE TUBE HAD TO BE FORCED OVER THE BOUGIE IN ORDER TO REMOVE THE BOUGIE. THE TUBE POSITION WAS CHECKED USING AN INTUBATING BRONCHOSCOPE, AND A SMALL FRAGMENT OF BLUE PLASTIC WAS VISUALISED IN THE AIRWAY (DESCRIBED AS 'IN THE TRACHEA') BUT MAY HAVE BEEN IN THE BRONCHUS. THE FRAGMENT OF BLUE PLASTIC WAS RETRIEVED USING ENDOSCOPIC GRASPER FORCEPS AND NO FURTHER COMPLICATIONS WERE ENCOUNTERED. INSPECTION OF THE BOUGIE REVEALED TWO AREAS OF ABRASION, ONE APPROX. 15 MM LONG (LIKELY TO BE THE SOURCE OF THE FOREIGN BODY) AND ANOTHER AT THE DISTAL END, APPROX. 10 MM LONG. IT IS THOUGHT THAT THE OVERSIZED BOUGIE FOULED A SHARP EDGE ON THE INSTRUMENT PORT, CAUSING IT TO GET STUCK AND FOR FRAGMENTS OF PLASTIC TO BE SHAVED OFF. PATIENT OUTCOME: A SHAVING, RETRIEVED WITH ENDOSCOPIC FORCEPS 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
    117558 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE G48303 E3850897 00827002483033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention