COOK STAGED EXTUBATION SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9. CORRECTION: H6 - ANNEX A AND ANNEX G. INVESTIGATION ¿ EVALUATION. ON (B)(6) 2025, A PROBLEM WAS ENCOUNTERED DURING A TRAINING SESSION ON A MANIKIN USING A COOK STAGED EXTUBATION SET. DURING THE USE OF THE EXTUBATION SET, A 10CM PIECE OF BLACK PLASTIC WAS FOUND TO BE OBSTRUCTING THE LUMEN OF THE REINTUBATION CATHETER. A CUSTOMER PROVIDED PHOTO REVEALS A BLACK PLASTIC TUBE EXITING THE GREEN, DISTAL PORTION OF THE CATHETER LUMEN. THE DEVICE DID NOT MAKE PATIENT CONTACT. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED CATHETER WAS RETURNED TO COOK FOR EVALUATION. VISUAL INSPECTION CONFIRMED A BLACK PIECE OF PLASTIC, MEASURING 11.2CM, WAS RETURNED WITH THE DEVICE. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, 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. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT AND ITS RELATED SUBASSEMBLY LOTS DID NOT REVEAL ANY QUALITY CONTROL DISCREPANCIES. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: "5. ADVANCE THE STAGED EXTUBATION WIRE, FLOPPY END FIRST, INTO THE ENDOTRACHEAL TUBE TO THE PREDETERMINED DEPTH. (FIGS. 1 AND 2) THE OPTIMAL INSERTION DEPTH SHOULD BE DETERMINED BY THE PHYSICIAN, TAKING INTO CONSIDERATION THE PATIENT¿S ANATOMY. NOTE: THE STAGED EXTUBATION WIRE HAS 5 DEPTH MARKINGS, INDICATING DISTANCE FROM THE DISTAL TIP. THE DOUBLE BAND IS POSITIONED 20 CM FROM THE DISTAL TIP, A SINGLE BAND AT 25 CM, A TRIPLE BAND AT 30 CM, A SINGLE BAND AT 35 CM AND A QUADRUPLE BAND AT 40 CM. (FIG. 3)." HOW SUPPLIED: "UPON REMOVAL FORM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDES THIS EVENT TO BE DUE TO A MANUFACTURER DEFICIENCY. THE BLACK PIECE OF PLASTIC RETURNED IN THE CATHETER IS THE CATHETER CHECKER USED IN QUALITY CONTROL PROCEDURES. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2 - THIS DEVICE AS IT IS NOT SOLD IN THE U.S.; HOWEVER, THIS DEVICE MEETS THE QUALIFICATIONS FOR A DEVICE THAT IS SAME/SIMILAR TO ONE THAT IS SOLD IN THE U.S. THE PRODUCT CODES REFLECT THE SAME/SIMILAR DEVICE. D2A - COMMON DEVICE NAME: ADDITIONAL: TUBE, TRACHEAL (W/WO CONNECTOR). D2B - PROCODE: ADDITIONAL PRODUCT CODES: BTR. H3 - DEVICE EVALUATED BY MFG? DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

ON NOVEMBER 7, 2025, A PROBLEM WAS ENCOUNTERED DURING A TRAINING SESSION ON A MANIKIN USING A COOK STAGED EXTUBATION SET. DURING THE USE OF THE EXTUBATION SET, A 10CM PIECE OF BLACK PLASTIC WAS FOUND TO BE OBSTRUCTING THE LUMEN OF THE REINTUBATION CATHETER. A CUSTOMER PROVIDED PHOTO REVEALS A BLACK PLASTIC TUBE EXITING THE GREEN, DISTAL PORTION OF THE CATHETER LUMEN. THE DEVICE DID NOT MAKE PATIENT CONTACT.