BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 20229642 · Received September 16, 2024

    Report

    Report Number
    1820334-2024-01227
    Event Type
    Injury
    Date Received
    September 16, 2024
    Report Date
    January 17, 2025
    Manufacturer
    COOK INC
    Product Code
    LRC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT DURING AN ETT EXCHANGE A CAE CATHETER BROKE. THE UPPER PART OF THE CATHETER WAS REMOVED, AND THE LOWER DISTAL END OF THE CAE CATHETER REMAINED WITHIN THE ETT. THE LOWER DISTAL END OF THE CATHETER WAS REMOVED WITH DIFFICULTIES. THE PATIENT WAS RE-INTUBATED, AND THE PROCEDURE WAS COMPLETED. MASK VENTILATION WAS DONE WITH 100% OXYGEN FOR THREE MINUTES. WITH MANUAL IN-LINE STABILIZATION AND WITH THE HELP OF A BOUGIE, AN ETT WAS REINSERTED. REVIEWS OF THE DOCUMENTATION, INCLUDING COMPLAINT HISTORY, INSTRUCTIONS FOR THE USE (IFU) FOR THE DEVICE AND QUALITY CONTROL PROCEDURES, 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 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 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, COOK COULD NOT ESTABLISH A DEFINITIVE CAUSE FOR THE REPORTED EVENT. IT IS STATED THAT THE PATIENT¿S OWN ANATOMY MADE FOR DIFFICULT INTUBATION COULD HAVE LED TO THIS EVENT IF TOO MUCH MANIPULATION OR STRESS WAS PLACED ON THE CATHETER. HOWEVER, THIS COULD NOT BE CONFIRMED WITH THE PROVIDED INFORMATION. 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

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.

    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.

    Description of Event or Problem · 0

    IN THE ARTICLE "FRAGMENTATION OF AIRWAY TUBE EXCHANGE CATHETER: A DANGEROUS SITUATION." THE FOLLOWING EVENT WAS REPORTED REGARDING A COOK AIRWAY EXCHANGE CATHETER: "A 62-YEAR MALE CASE OF ACUTE ODONTOID FRACTURE PRESENTING WITH SPASTIC QUADRIPARESIS WAS POSTED FOR POSTERIOR SPINE DECOMPRESSION AND OCCIPITO-CERVICAL FIXATION AFTER C1 ARCH EXCISION. THE PATIENT HAD A POOR GCS (E2V2M2). THE PATIENT WAS RECEIVED FROM THE TRAUMA INTENSIVE CARE UNIT (ICU) TO THE OPERATION THEATER, WHERE HE WAS ADMITTED THE PREVIOUS DAY AND INTUBATED THE DAY BEFORE WITH POLYVINYL CHLORIDE (PVC) CUFFED ENDOTRACHEAL TUBE (ETT) OF INTERNAL DIAMETER (ID) 8 MM. PATIENT WAS IDENTIFIED AS DIFFICULT INTUBATION WITH A SHORT NECK. HE WAS HEMODYNAMICALLY STABLE WITH NO OTHER SYSTEMIC INJURIES AND ABNORMALITIES. THE PATIENT WAS ALREADY ON AN INJECTION OF FENTANYL 50 MCG/HR INTRAVENOUS (IV) AND AN INJECTION OF MIDAZOLAM 2 MG/HR IV. IN THE OPERATING THEATER, MONITORS WERE ATTACHED, AND VITALS WERE RECORDED. THE PATIENT NEEDED A PRONE POSITION FOR SURGERY; HENCE, WE PLANNED TO EXCHANGE THE ETT WITH A WIRE-REINFORCED FLEXO-METALLIC ETT OF ID 7.0 MM BY USING COOK¿S AIRWAY EXCHANGER CATHETER (CAEC) 14F, 83 CM IN LENGTH. GENERAL ANESTHESIA WAS ADMINISTERED BY INJECTION FENTANYL 100 MCG IV BOLUS AND PROPOFOL 100 MG IV¿INJECTION OF VECURONIUM 5 MG IV GIVEN. AFTER LUBRICATION, THE CIRCUIT WAS DISCONNECTED, AND THE CAEC WAS INSERTED INTO THE ENDOTRACHEAL TUBE. AFTER PROPER INSERTION OF CAEC, WHEN THE ETT WAS ABOUT TO BE REMOVED, IT WAS NOTED THAT THE AIRWAY EXCHANGER HAD BEEN BROKEN IN THE MIDDLE. THE BROKEN UPPER PART OF CAEC WAS REMOVED, AND THE LOWER PART REMAINED INSIDE THE TUBE [FIGURE 1A]. IMMEDIATELY, THE ETT WAS CONNECTED TO THE CIRCUIT, AND VENTILATION WAS CHECKED. GOOD CHEST RISE WAS PRESENT. THE WHOLE UNIT OF THE ENDOTRACHEAL TUBE WITH THE CAEC WAS REMOVED AFTER DEFLATING THE CUFF [FIGURE 1B]. MAGILL¿S FORCEPS AND LARYNGOSCOPE WERE KEPT ON STANDBY IN CASE CAEC WOULD HAVE LEFT BEHIND. FORTUNATELY, THE AMPUTATED CAEC WAS REMOVED IN OUR CASE ALONG WITH ETT. MASK VENTILATION WAS DONE WITH 100% OXYGEN FOR 3 MINUTES. WITH MANUAL IN-LINE STABILIZATION AND WITH THE HELP OF A BOUGIE, WE WERE SUCCESSFUL IN INTUBATING THE AIRWAY WITH FLEXO-METALLIC ETT. THE CIRCUIT WAS CONNECTED. BILATERAL EQUAL AND ADEQUATE BREATH SOUNDS WERE PRESENT. THE PATIENT POSITION CHANGED TO PRONE. THE SURGERY WAS COMPLETED UNEVENTFULLY." NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REFERENCE: SWARO, S., SRIRAMKA, B., & SAMAL, R. (2023). FRAGMENTATION OF AIRWAY TUBE EXCHANGE CATHETER: A DANGEROUS SITUATION. SAUDI JOURNAL OF ANAESTHESIA, 17(3), 440¿441. HTTPS://DOI.ORG/10.4103/SJA.SJA_689_22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554061 COOK AIRWAY EXCHANGE CATHETER LRC CHANGER, TUBE, ENDOTRACHEAL LRC COOK INC G07873 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention