BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET

    MDR report key: 6546990 · Received May 5, 2017

    Report

    Report Number
    1820334-2017-00763
    Event Type
    Injury
    Date Received
    May 5, 2017
    Report Date
    July 28, 2017
    Manufacturer
    COOK INC
    Product Code
    BWC
    PMA / PMN Number
    K013916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS,DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, DEVICE FAILURE IS RELATED TO PATIENT CONDITION. THE REPORTED EMPHYSEMA AFFECTED THE THORAX NECK AND FACE AND THE TONGUE BECAME DISTINCTIVELY SWOLLEN. THE AUTHOR INDICATED THAT THIS CONDITION LED TO ATTEMPTS TO REPOSITION THE ORIGINAL TRACHEOSTOMY BEFORE THE EMERGENCY CRICOTHYROTOMY WAS ATTEMPTED WITH THE COMPLAINT DEVICE. THE AUTHOR INDICATED THAT PALPATION OF THE THYROID CARTILAGE WAS DIFFICULT AND THAT INCREASED RESISTANCE WAS ENCOUNTERED AS THE DEVICE WAS ADVANCED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BRADYCARDIC AND SUBSEQUENT HEART ARREST. RESUSCITATIVE MEASURES WERE IMMEDIATELY UNDERTAKEN HOWEVER DUE TO THE BAD CLINICAL PROGNOSIS THE MEASURES LASTED ABOUT 10 MINUTES. OXYGENATION WAS ACCOMPLISHED VIA FACIAL MASK. THE PATIENT PERSISTED IN ASYSTOLE. [(B)(4)].

    Description of Event or Problem · 1

    FUTILE CRICOTHYROTOMY WITH AN INDUSTRIAL MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET AFTER SELDINGER. CASU, S, BOOKE, M; ANASTH INTENSIVMED, 2017; 58:157-160. A COMPANY REPRESENTATIVE ADVISED OBTAINING THE ABOVE REFERENCED ARTICLE 'THIRD HAND' FROM A CUSTOMER THROUGH ANOTHER REPRESENTATIVE. THE ARTICLE REPORTS THAT A PATIENT WITH HYPOXIA RESULTING FROM PNEUMONIA WAS UNDER INTENSIVE MEDICAL CARE FOLLOWING PRIMARY SUCCESSFUL PRE-CLINICAL REANIMATION. THE ARTICLE REPORTS THAT THIS PATIENT ON LONG TERM MECHANICAL VENTILATION DISLOCATED AN EXISTING TRACHEAL CANNULA RESULTING IN SUBCUTANEOUS EMPHYSEMA. THE EMPHYSEMA AFFECTED THE THORAX, NECK AND FACE AND THAT THE PATIENTS' TONGUE BECAME DISTINCTLY SWOLLEN. THE AUTHOR REPORTS THAT DIFFICULTY WAS ENCOUNTERED DUE TO THE NECK SWELLING AND THE NECESSARY EMERGENCY CRICOTHYROTOMY USING A MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET COULD NOT BE PERFORMED; THEREFORE THE PHYSICIAN SWITCHED TO A CONVENTIONAL CRICOTHYROTOMY FOR AIRWAY ACCESS. THE JOURNAL ARTICLE DOES NOT PROVIDE INFORMATION RELATING TO THE OUTCOME OF THE PROCEDURE NOR THE STATUS OF THE PATIENT FOLLOWING CONVENTIONAL CRICOTHYROTOMY TO RESTORE AIRWAY ACCESS FOLLOWING THE INADVERTENT DISLOCATION OF THE INITIAL UNSPECIFIED CATHETER. THE EVENT IS UNDER INVESTIGATION. A COMPANY SALES REPRESENTATIVE HAS AN APPOINTMENT TO MEET WITH THE AUTHOR OF THE ARTICLE ON 05/09/2017 TO DISCUSS THE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT WOULD WARRANT A FOLLOW-UP SUBMISSION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    FUTILE CRICOTHYROTOMY WITH AN INDUSTRIAL MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET AFTER SELDINGER. CASU, S, BOOKE, M; ANASTH INTENSIVMED, 2017; 58:157-160. A COMPANY REPRESENTATIVE ADVISED OBTAINING THE ABOVE REFERENCED ARTICLE 'THIRD HAND' FROM A CUSTOMER THROUGH ANOTHER REPRESENTATIVE. THE ARTICLE REPORTS THAT A PATIENT WITH HYPOXIA RESULTING FROM PNEUMONIA WAS UNDER INTENSIVE MEDICAL CARE FOLLOWING PRIMARY SUCCESSFUL PRE-CLINICAL REANIMATION. THE ARTICLE REPORTS THAT THIS PATIENT ON LONG TERM MECHANICAL VENTILATION DISLOCATED AN EXISTING TRACHEAL CANNULA RESULTING IN SUBCUTANEOUS EMPHYSEMA. THE EMPHYSEMA AFFECTED THE THORAX, NECK AND FACE AND THAT THE PATIENTS' TONGUE BECAME DISTINCTLY SWOLLEN. THE AUTHOR REPORTS THAT DIFFICULTY WAS ENCOUNTERED DUE TO THE NECK SWELLING AND THE NECESSARY EMERGENCY CRICOTHYROTOMY USING A MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET COULD NOT BE PERFORMED; THEREFORE THE PHYSICIAN SWITCHED TO A CONVENTIONAL CRICOTHYROTOMY FOR AIRWAY ACCESS. THE JOURNAL ARTICLE DOES NOT PROVIDE INFORMATION RELATING TO THE OUTCOME OF THE PROCEDURE NOR THE STATUS OF THE PATIENT FOLLOWING CONVENTIONAL CRICOTHYROTOMY TO RESTORE AIRWAY ACCESS FOLLOWING THE INADVERTENT DISLOCATION OF THE INITIAL UNSPECIFIED CATHETER. THE EVENT IS UNDER INVESTIGATION. A COMPANY SALES REPRESENTATIVE HAS AN APPOINTMENT TO MEET WITH THE AUTHOR OF THE ARTICLE ON 05/09/2017 TO DISCUSS THE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT WOULD WARRANT A FOLLOW-UP SUBMISSION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION REC'D 05/17/2017: THE PATIENT WAS BRADYCARDIC AND SUBSEQUENT HEART ARREST. RESUSCITATIVE MEASURES WERE IMMEDIATELY UNDERTAKEN HOWEVER DUE TO THE BAD CLINICAL PROGNOSIS THE MEASURES LASTED ABOUT 10 MINUTES. OXYGENATION WAS ACCOMPLISHED VIA FACIAL MASK. THE PATIENT PERSISTED IN ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328079 MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET BWC NEEDLE, EMERGENCY AIRWAY BWC COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other