COOK AIRWAY EXCHANGE CATHETER
Report
- Report Number
- 1820334-2024-01198
- Event Type
- Injury
- Date Received
- September 9, 2024
- Report Date
- January 20, 2025
- Manufacturer
- COOK INC
- Product Code
- LRC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION ¿ EVALUATION: ON 29AUG2024, AN EVENT INVOLVING A DEVICE FROM AN UNKNOWN LOT WAS REPORTED. THE COMPLAINT IS FROM A JOURNAL ARTICLE INVOLVING THIS COOK DEVICE. THE ARTICLE STATED THAT THE CAE WAS USED TO MAINTAIN AIRWAY ACCESS DURING A TRIAL OF EXTUBATION. THE ETT WAS REMOVED OVER THE CAE DEVICE AND THE PROVIDERS DETERMINED THERE WAS NO NEED TO REPLACE THE ETT, SO THE CAE WAS REMOVED. NO RESISTANCE WAS NOTED DURING REMOVAL; HOWEVER, THE DISTAL PORTION OF THE CAE DEVICE WAS MISSING. A 15 CM PIECE OF THE CAE DEVICE REMAINED IN THE TRACHEA. THE PATIENT REQUIRED REMOVAL OF THE PORTION OF THE CAE UNDER ANESTHESIA AND WAS RE-INTUBATED FOR TWO HOURS AFTER THE PROCEDURE. A CHEST RADIOGRAPH WAS TAKEN TO CONFIRM NO MISSING SEGMENTS LEFT BEHIND. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, 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. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. THE DHR WAS UNABLE TO BE COMPLETED, DUE TO THE LACK OF LOT INFORMATION FROM THE COMPLAINT FACILITY. COOK ALSO REVIEWED PRODUCT LABELING: THERE IS AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, C_T_CAE_REV6. WARNINGS: ENSURE PROPER SIZING OF THE COOK AIRWAY EXCHANGE CATHETER WITHIN DOUBLE-LUMEN ENDOTRACHEAL TUBE. FAILURE TO DO SO MAY CAUSE SMALL FRAGMENTS TO BE SHAVED OFF DURING REMOVAL OF THE COOK AIRWAY EXCHANGE CATHETER. ENDOTRACHEAL TUBE EXCHANGE: 1. BEFORE ADVANCING THE COOK AIRWAY EXCHANGE (CAE) CATHETER INTO THE ENDOTRACHEAL TUBE TO BE REPLACED, CONFIRM CORRECT ENDOTRACHEAL TUBE POSITION. 3. ADVANCE THE CAE CATHETER, SIDE PORTED END FIRST, INTO THE ENDOTRACHEAL TUBE TO BE REPLACED. NOTE: IT IS RECOMMENDED THAT A STERILE LUBRICANT BE APPLIED TO THE ORIFICE OF THE ENDOTRACHEAL TUBE PRIOR TO INTRODUCTION OF CAE CATHETER. HOW SUPPLIED: UPON REMOVAL FORM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. EVIDENCE GATHERED UPON REVIEW OF THE DMR, IFU AND WITH NO PRODUCT RETURN, COOK WAS NOT ABLE TO FIND EVIDENCE THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO FIND EVIDENCE OF NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. IT IS POSSIBLE THE CATHETER EXPERIENCED STRETCHING AND WAS EXPIRED. THE EXPIRATION DATE OF THE PRODUCT SHOULD BE CHECKED PRIOR TO USE TO AVOID HELP PREVENT AN EVENT LIKE WHAT OCCURRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK 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.
E1 - CUSTOMER (PERSON): ADDRESS: (B)(6). E3- OCCUPATION: DEPARTMENT OF ANAESTHESIA. G4 - PMA/510(K) #: EXEMPT. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN THE ARTICLE, "REMOVAL OF BROKEN AIRWAY EXCHANGER IN A PATIENT POST THYROID SURGERY" THE FOLLOWING WAS REPORTED REGARDING A COOK AIRWAY EXCHANGE CATHETER: "A 51YEAR OLD LADY, WEIGHING 59KGS WAS SCHEDULED FOR TOTAL THYROIDECTOMY. SHE HAD A SWELLING IN THE NECK FOR 4 YEARS, IDENTIFIED AS MULTINODULAR GOITRE WITH SYMPTOMS OF HYPERTHYROIDISM. SHE WAS ON TREATMENT AND WAS EUTHYROID ON PRESENTATION, WITH NO COMORBIDITY. THERE WERE NO FINDINGS OF A DIFFICULT AIRWAY, WITH MOUTH OPENING OF MORE THAN TWO FINGER BREATHS AND NO RESTRICTION OF NECK MOVEMENTS. NO FEATURES OF RETROSTERNAL EXTENSION. ALL INVESTIGATIONS WERE NORMAL. GENERAL ANAESTHESIA ACCOMPANIED BY ORAL ENDOTRACHEAL INTUBATION WITH A 7.0 MM INTERNAL DIAMETER CUFFED TUBE ALONG WITH CONTROLLED MECHANICAL VENTILATION WAS PLANNED. THE LARYNGEAL VIEW FOR INTUBATION WAS CORMACK-LEHANE 1 WITH NO DIFFICULTY IN TUBE PASSAGE. THE SURGERY WAS 7 HLONG. SHE WAS EXTUBATED AFTER RECOVERY. FOLLOWING EXTUBATION, SHE WAS ASKED TO VOCALISE TO ASCERTAIN THE STATUS OF THE VOCAL CORDS. ALTHOUGH SHE WAS ABLE TO VOCALISE, IT WAS ACCOMPANIED BY NOISY BREATHING. STEROID INJECTION WAS SUPPLEMENTED ALONG WITH NEBULISATION, BUT THE STRIDOR DID NOT SUBSIDE. HENCE, WE PLANNED TO RE-INTUBATE, TREAT CONSERVATIVELY AND OBSERVE FOR 48 HOURS. PATIENT WAS INDUCED AND ON DIRECT LARYNGOSCOPY, THERE WAS LARYNGEAL EDEMA, HENCE A ONE SIZE SMALLER TUBE WAS INSERTED. PROCEDURE WAS UNEVENTFUL AND PATIENT WAS LEFT ON T-PIECE WITH OXYGEN AT 2L/MIN. FORTY-EIGHT HOURS LATER, SHE WAS EXTUBATED AND AN AEC WAS DEVISED TO ACT AS A CONDUIT UNTIL IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO BREATHE AROUND THE TUBE WITH NO DISTRESS SO IN CASE REVERSIBLE EXTUBATION IF NECESSARY COULD BE PERFORMED. A WELL LUBRICATED COOK AEC (11 FR, 83 CM, COOK CRITICAL CARE, USA) WAS PASSED THROUGH THE LUMEN OF THE ETT TILL THE 24-CM MARK AT THE LEVEL OF INCISOR TEETH. THE ETT WHICH WAS INSIDE WAS METICULOUSLY REMOVED OVER THE AEC. ONCE THE CONSULTANTS WERE SATISFIED OF HER BREATHING CONDITION, THE AEC WAS TAKEN OUT. HOWEVER, IN SPITE OF NO RESISTANCE, THE DISTAL PART OF THE AEC WAS MISSING ON REMOVAL AS 15CM OF THE DISTAL PART WAS SNAPPED. (FIG. 1) THE BROKEN PART WAS IN THE TRACHEA AROUND 1 CM BELOW THE VOCAL CORD WHICH WAS CONFIRMED BY A FIBREOPTIC BRONCHOSCOPY. SHE WAS IMMEDIATELY SHIFTED TO THE OPERATION THEATRE FOR REMOVAL. THE CONSULTANTS COUNSELLED THE PATIENT AND RELATIVES FOR CONSENT. GENERAL ANAESTHESIA WAS GIVEN. RIGID BRONCHOSCOPY WAS CONDUCTED. MAINTENANCE OF ANAESTHESIA WAS DONE USING SEVOFLURANE AND OXYGEN THROUGH THE PORT OF BRONCHOSCOPE. THE MISSING PART WAS IMMEDIATELY RECOGNISED AND REMOVED. ONCE RETRIEVED, SHE WAS INTUBATED USING A 6.5MM CUFFED ORAL ETT UNDER DIRECT LARYNGOSCOPY AND SHIFTED BACK TO THE POST-OPERATIVE CARE UNIT FOR MONITORING FOR 2¿3 HOURS BEFORE REASSESSMENT FOR EXTUBATION. A CHEST RADIOGRAPH WAS TAKEN TO CONFIRM NO MISSING SEGMENTS LEFT BEHIND. SHE REMAINED STABLE AND WAS EXTUBATED AFTER 2 H FOLLOWING A LEAK TEST TO ENSURE THERE WAS NO AIRWAY EDEMA FOLLOWING THE REPEATED AIRWAY MANIPULATION." NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REFERENCE MISQUITH, J., BHATTACHARYA O., NAMBIAR H., KAMATH S., RAO S. (2024). REMOVAL OF BROKEN AIRWAY EXCHANGER IN A PATIENT POST THYROID SURGERY. TRENDS IN ANAESTHESIA AND CRITICAL CARE, 54 (2024), 101323. HTTPS://DOI.ORG/10.1016/J.TACC.2023.101323.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2337079 | COOK AIRWAY EXCHANGE CATHETER | LRC CHANGER, TUBE, ENDOTRACHEAL | LRC | COOK INC | G06732 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |