MELKER EMERGENCY CRICOTHYROTOMY CATHETER
Report
- Report Number
- 1820334-2022-01009
- Event Type
- Death
- Date Received
- June 8, 2022
- Report Date
- March 27, 2023
- Manufacturer
- COOK INC
- Product Code
- BWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL COMMON NAME: JOH TUBE TRACHEOSTOMY AND TUBE CUFF. ADDITIONAL PRO CODE: JOH. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
CORRECTION: H6 - ANNEX G. INVESTIGATION ¿ EVALUATION. ON 25MAY2022, VALLEY HEALTH (UNITED STATES) REPORTED THAT A MELKER EMERGENCY CRICOTHYROTOMY CATHETER (RPN AND LOT# UNKNOWN) WAS UNABLE TO BE PLACED. A FEMALE PATIENT REPORTED TO THE HOSPITAL WITH DIFFICULTY BREATHING, A CONSTRICTED AIRWAY, AND AN ENLARGED TONGUE RELATED TO AN ACE INHIBITOR REACTION. THE VOCAL CORDS WERE NOT VISIBLE, AND THE PATIENT WAS ASSESSED WITH A MALLAMPATI SCORE CLASS 4. IT WAS DEEMED UNFEASIBLE TO PLACE AN ENDOTRACHEAL TUBE, SO AIRWAY ACCESS WAS ATTEMPTED WITH THE MELKER DEVICE. THE PATIENT REPORTEDLY HAD A HIGH BMI WHICH MADE THE DEVICE DIFFICULT TO USE AND TRACHEAL LANDMARKS COULD NOT BE PALPATED. DURING THE PLACEMENT ATTEMPT, THE WIRE GUIDE MAY HAVE LANDED IN A FALSE AIRWAY. A VIABLE AIRWAY WAS UNABLE TO BE SECURED. THE PATIENT¿S OXYGEN SATURATION (SPO2) ¿DROPPED TOO LOW¿ AND THERE WERE NO OTHER MEANS AVAILABLE TO VENTILATE/OXYGENATE THE PATIENT. THE PATIENT SUBSEQUENTLY EXPIRED. REVIEWS OF THE DOCUMENTATION, INCLUDING THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE COMPLAINT DEVICE LOT WAS NOT PROVIDED BY THE FACILITY. A REVIEW OF SALES RECORDS TO THE USER FACILITY OF A THREE-YEAR PERIOD PRIOR TO THE EVENT DATE IDENTIFIED FOUR POSSIBLE LOTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOTS 10319614, 13582755, 13841290, AND 14455915 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT NO OTHER COMPLAINTS HAVE BEEN ASSOCIATED WITH THESE LOT NUMBERS. COOK ALSO REVIEWED PRODUCT LABELING. THE MOST RECENT INSTRUCTIONS FOR USE (IFU) [C_T_TCCS_REV8] SUPPLIED WITH THE MELKER EMERGENCY CRICOTHYROTOMY CATHETER SETS WAS REVIEWED FOR INFORMATION RELATED TO THE REPORTED FAILURE. PER THE IFU: ¿INTENDED USE MELKER CUFFED AND UNCUFFED EMERGENCY CRICOTHYROTOMY CATHETER SETS ARE INTENDED TO ESTABLISH EMERGENCY AIRWAY ACCESS WHEN ENDOTRACHEAL INTUBATION CANNOT BE PERFORMED. AIRWAY ACCESS IS ACHIEVED USING PERCUTANEOUS ENTRY (SELDINGER) TECHNIQUE VIA THE CRICOTHYROID MEMBRANE. SUBSEQUENT DILATION OF THE TRACT AND TRACHEAL ENTRANCE SITE PERMITS PASSAGE OF THE EMERGENCY AIRWAY CATHETER. WARNINGS: CONSIDERATION SHOULD BE GIVEN TO THE FOLLOWING MEDICAL AND ANATOMIC CONDITIONS: DISTORTED ANATOMY. INSTRUCTIONS FOR USE: 1. IDENTIFY THE CRICOTHYROID MEMBRANE BETWEEN THE CRICOID AND THYROID CARTILAGES. 2. CAREFULLY PALPATE THE CRICOTHYROID MEMBRANE AND, WHILE STABILIZING THE CARTILAGE, MAKE A VERTICAL INCISION IN THE MIDLINE¿¿ THE INFORMATION GATHERED FROM THE REVIEW OF THE IFU AND DHR SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT UNFAVORABLE PATIENT ANATOMY CREATED SIGNIFICANT DIFFICULTIES DURING PATIENT INTUBATION AND IMPACTED THE EFFICACY OF THE MELKER DEVICE. THE CUSTOMER STATED THE PATIENT HAD A HIGH BMI, WHICH CREATED SIGNIFICANT DIFFICULTIES IN PALPITATING TRACHEAL LANDMARKS. ADDITIONALLY, IT WAS BELIEVED THE PATIENT WAS NOT A SUITABLE CANDIDATE FOR A SELDINGER CRICOTHYROTOMY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IT WAS REPORTED THAT AN ATTEMPT TO USE A MELKER EMERGENCY CRICOTHYROTOMY CATHETER ON A FEMALE PATIENT WAS UNSUCCESSFUL. THE PATIENT CAME INTO THE HOSPITAL WITH AN ENLARGED TONGUE AND DIFFICULTY BREATHING. AS THERE WAS NO WAY TO INSERT A BREATHING TUBE INTO THE PATIENT, THIS DEVICE WAS USED IN AN EMERGENCY CRICOTHYROTOMY WITHOUT SUCCESS. THE PATIENT WAS REPORTED TO HAVE A VERY HIGH BMI, MAKING USE OF THE DEVICE DIFFICULT. THE PATIENT EXPIRED FOLLOWING THE INABILITY TO SECURE A VIABLE AIRWAY. ADDITIONAL INFORMATION REGARDING DEVICE AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
IN ADDITIONAL INFORMATION RECEIVED ON 13JUN2022, IT WAS REPORTED THAT THE PATIENT HAD A CONSTRICTED AIRWAY DUE TO PRESCRIPTION DRUG (ACE INHIBITOR) USAGE. SWELLING OF THE TONGUE (MALLAMPATI CLASS IV) MADE IT IMPOSSIBLE TO PASS AN ENDOTRACHEAL (ET) TUBE OR VISUALIZE THE VOCAL CORDS. THE PATIENT HAD A HIGH BODY MASS INDEX (BMI) AND TRACHEAL LANDMARKS COULD NOT BE PALPATED. ATTEMPTED PASSAGE OF THE WIRE MAY HAVE ENDED UP IN A FALSE AIRWAY. PATIENT BLOOD OXYGEN SATURATION LEVEL (SP02) WAS DROPPING TOO LOW AND NO OTHER MEANS TO VENTILATE OR OXYGENATE THE PATIENT COULD BE DONE. IT WAS THOUGHT THAT THE PATIENT WAS NOT A CANDIDATE FOR A SELDINGER CRICOTHYROTOMY. A SURGICAL OPTION WOULD HAVE BEEN BETTER, BUT BEING A REMOTE FACILITY, NO ONE WAS ABLE TO FACILITATE THAT APPROACH.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2160912 | MELKER EMERGENCY CRICOTHYROTOMY CATHETER | BWC NEEDLE, EMERGENCY AIRWAY | BWC | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Death |