BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 18665793 · Received February 8, 2024

    Report

    Report Number
    3002808486-2024-00022
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    January 31, 2024
    Report Date
    May 2, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    10827002236469
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K161813. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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). SUMMARY OF INVESTIGATIONAL FINDINGS: THE FROVA RUPTURED AND AFTER INTUBATING THE PATIENT THE SEGMENT WAS REMOVED IN ITS ENTIRETY DURING FIBROSCOPY AND REPORTEDLY THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE FROVA INTRODUCER, THE STIFFENING STYLET, AND TWO UNOPENED RAPI-FIT ADAPTERS WERE RETURNED. THE STYLET WAS CURVED STARTING 160MM FROM THE DISTAL END. THE FROVA INTRODUCER WAS SEVERELY DAMAGED WITH KINKS/SCRAPINGS AND HAD FRACTURED 582MM FROM THE PROXIMAL END. A CLOSER INVESTIGATION OF THE FRACTURED AREA FOUND NO IMPERFECTION IN THE WALL THICKNESS, BUT DID MERELY REVEAL INDICATIONS OF THE MATERIAL BEING CUT. HOWEVER, BASED ON THE INFORMATION PROVIDED AND WITHOUT ANY INFORMATION CONCERNING THE ENDOTRACHEAL TUBE OR THE LARYNGOSCOPE, THE EXACT REASON FOR THE FRACTURE OR THE SCRAPINGS CANNOT BE DETERMINED, BUT THE COMPLAINT WILL BE REOPENED IN CASE ADDITIONAL INFORMATION SHOULD BE PROVIDED. THE FROVA INTUBATING INTRODUCER HAS BEEN DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6MM OR LARGER AND THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE INSTRUCT THAT THE STIFFENING STYLET MUST BE REMOVED WHEN THE INTRODUCER IS ADVANCED APPROXIMATELY 2-3CM INTO THE TRACHEA AND WARN THAT CARE MUST BE TAKEN WHEN INTRODUCING/REMOVING THE INTRODUCER FROM THE ENDOTRACHEAL TUBE; CONTACT WITH SHARP EDGES ON THE INTERNAL SURFACE OF THE TUBE MAY CAUSE SMALL FRAGMENTS TO BE SHAVED OFF THE INTRODUCER DURING INTRODUCTION/REMOVAL. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE VIDEOLARYNGOSCOPY PROCEDURE, AFTER HAVING INTRODUCED THE FROVA INTO THE TRACHEA AND HAVING REMOVED THE RELATIVE STYLET, THE FROVA BREAKS, WITH DETACHMENT OF ITS TERMINAL SECTION IN THE TRACHEA. OUR FIBROBRONCHOSCOPIST COLLEAGUES ARE IMMEDIATELY ALERTED AND, AFTER HAVING INTUBATED THE PATIENT, THEY PROCEED WITH THE OPERATIVE FIBRO-CHRONOCHOSCOPY, DURING WHICH THEY COMPLETELY EXTRACT THE DETACHED FROVA SEGMENT. PATIENT OUTCOME: THE PATIENT REQUIRED ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE PATIENT WHO WAS SENT TO THE INTENSIVE CARE UNIT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305999 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE E4406178 10827002236469

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention