BEUDAMED
    FDA Adverse Event Death Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 10022981 · Received May 5, 2020

    Report

    Report Number
    3002808486-2020-00503
    Event Type
    Death
    Date Received
    May 5, 2020
    Date of Event
    April 28, 2020
    Report Date
    July 29, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER CONSIDERED REPORTABLE AS INVESTIGATION CONCLUDED THAT THERE WAS NO EVIDENCE TO SUGGEST DEVICE FAILURE. THE PHYSICIAN HAD A PREFERENCE TO USE THE STIFFENED FROVA INTRODUCER, BUT RECEIVED AND USED THE NON-STIFFENED FROVA INTRODUCER INSTEAD, BUT ACCORDING TO THE INVESTIGATOR AND MEDICAL ADVISORS, THIS COULD NOT ALONE HAVE CONTRIBUTED TO THE PATIENT¿S DEATH - A PATIENT DEATH DURING INTUBATION, IS USUALLY THE RESULT OF PATIENT AIRWAY ANATOMY, JAW SIZE AND SHAPE, AND OTHER FACTORS, RATHER THAN EQUIPMENT FAILURES, WHY IT IS CONSIDERED THAT THE DEVICE DID NOT HAVE A DIRECT FACTOR TO THE PATIENT DEATH AND THIS OCCURRENCE DOES NOT MEET THE CRITERIA FOR A REPORTABLE COMPLAINT. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT THE CUSTOMER PREFERRED C-CAE-/-FII (WITH STYLET) BUT THIS WAS ON BACKORDER, SO C-CAE-/-FIC (WITHOUT STYLET) WAS USED. PATIENT PASSED AWAY, BUT THE DEATH REASON COULD HAVE BEEN SOMETHING TOTALLY DIFFERENT AND THE PATIENT COULD HAVE PASSED AWAY EVEN IF THE FROVA WITH THE INNER CANNULA WAS AVAILABLE AND USED. THE DOCTOR INTUBATING THE PATIENT HAD THE STANDARD, NON-STIFFENED FROVA INSTEAD OF THE STIFFENED ONE PREFERRED, BUT THAT ALONE SHOULD NOT HAVE CONTRIBUTED TO THE PATIENT¿S DEATH AND REPORTEDLY THE DEATH REASON COULD HAVE BEEN SOMETHING TOTALLY DIFFERENT. IT IS NOT REPORTED IF ANY OTHER OPTIONS WERE TRIED (BRONCHOSCOPE, EMERGENCY TRACHEOSTOMY KIT, ETC) AND, THERE IS NO INFORMATION OF PATIENT AIRWAY ANATOMY, JAW SIZE AND SHAPE AND OTHER FACTORS. THE POINT BEING THAT THERE ARE NUMEROUS OPTIONS AVAILABLE, AND JUST BECAUSE THE FROVA THAT WAS AVAILABLE WAS THE UNSTIFFENED ONE RATHER THAN THE PERSONAL PREFERENCE OF THE STIFFENED ONE FOR THE PERSON INTUBATING, WOULD NOT BE CLASSED AS A FAILURE MODE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE FROVA DEVICE USED WAS MANUFACTURED TO SPECIFICATIONS, BUT COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. 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). PMA/510(K): K161813. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE CUSTOMER WAS UNABLE TO RECEIVE THEIR PREFERRED PRODUCT; FROVA BOUGIE WITH STIFFENING CANNULA BECAUSE OF THE UNPRECEDENTED SITUATION WITH COVID-19 CREATING A BACKORDER. (C-CAE-/-FII). THEY WERE OFFERED AN ALTERNATIVE; FROVA BOUGIE WITHOUT STIFFENING CANNULA. (C-CAE-/-FIC). YESTERDAY A PATIENT PASSED AWAY AND IN THE ANOMALY REPORT, THEY MENTIONED THAT THE ABSENCE OF THE INNER CANNULA MIGHT HAVE HAD AN INFLUENCE. THEY ARE NOT BLAMING COOK AT ALL, OR THAT WE COULD NOT DELIVER, HOWEVER, THEY NEEDED TO DOCUMENT ALL FACTORS THAT COULD HAVE CONTRIBUTED TO THE DEATH OF THE PATIENT. STILL, THE DEATH REASON COULD HAVE BEEN SOMETHING TOTALLY DIFFERENT AND THE PATIENT COULD HAVE PASSED AWAY EVEN IF THE FROVA WITH THE INNER CANNULA WAS AVAILABLE AND USED. PATIENT OUTCOME: THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487987 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death