MAUDE Adverse Event Report: COOK INC COOK AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Fetterman, d, dubovoy, a, reay, m,; unforeseen esophageal misplacement of airway exchange catheter leading to gastric perforation.Anesthesiology 2006; 104: 1111-1112.The above referenced article reports that a patient underwent an unspecified surgical procedure with placement of a 7.0 mm single lumen endotracheal tube.Patient reportedly had a difficult airway secondary to external radiation to the face for an orbital basal cell carcinoma.Once fully awake with intact neuromuscular function, the patient underwent extubation over a cook airway exchange catheter (aec) secured with tape at the lips at 35 cm to allow a margin of safety from accidental dislodgment.The patient was noticed to have an occasional belch during transfer to post-operative care.The patient was switched from face mask to oxygen through the aec during his stay in the post-op care unit.The patient reported pain disproportionate to his surgery one hour into his stay in the unit.The patient¿s abdomen was noted to be remarkably distended, associated with belching.Oxygen through the aec was discontinued.Chest and abdominal radiographs illustrated free air under the diaphragm and massive gastric distention.The patient underwent emergent laparoscopy; the aec was noted to be in the esophagus on repeat fiberoptic intubation for the surgery.Diagnostic laparoscopy revealed a small perforation on the lesser curvature of the stomach consistent with gastric overdistension, which was subsequently repaired.Whether the perforation was caused directly by the device or gastric distension from oxygen insufflation is unknown.The patient subsequently made a full recovery and was discharged from hospital a week later.The author states that "in this case, the aec was inserted too far; the literature recommends 22¿25 cm for oral placement and 27¿30 cm for nasal placement.".

Manufacturer Narrative

Investigation ¿ evaluation: a review of the documentation, drawings, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation, and no issues were found related to the reported issue.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.The complainant device lot number is unknown.Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted.The device is shipped with instruction for use (ifu), which state that the catheter is intended for uncomplicated atraumatic endotracheal tube exchange.However, this patient was reportedly known to have a difficult airway.It also warns to: ¿properly position the cae (cook airway exchange) catheter within the endotracheal tube by aligning the appropriate centimeter mark on the cae catheter with the corresponding centimeter mark on the endotracheal tube.This placement is determined by visualizing the indicated centimeter length of the endotracheal tube, in place, as shown on its surface scale.(for example, an endotracheal tube that has been shortened to 24 cm should have the 24 cm marker of the cae catheter aligned at the 24 cm mark of the endotracheal tube.)¿ yet, the endotracheal tube was reportedly secured at 22 cm to the lip, while the airway exchange catheter was secured at 35 cm to the lip.Therefore, the cae catheter was not properly aligned with the endotracheal tube, and was inserted 13 cm further than the endotracheal tube.Further, the paper indicated that a high-pressure (2 l/min) oxygen source was connected to the proximal end of the exchange catheter.Per the ifu, if a high-pressure oxygen source is used for insufflation (e.G., jet ventilator), begin at lower pressure and work up gradually.There is no indication that the pressure was started lower and slowly increased to 2 l/min versus starting straight from that flow rate.After the procedure, the patient was switched from facemask to oxygen through the cae catheter with an unknown oxygen insufflation flow rate.A high flow of oxygen or oxygen jet ventilation delivered via the lumen of the catheter or the bronchoscope may result in barotrauma and/or other organ damage.Finally, the paper states that a radiograph showed massive gastric distention or bloating of the stomach due to excess air delivery.The ifu notes that the use of a high-pressure oxygen source should only be considered if the patient has sufficient deflation of the insufflated gas volume, which clearly was not the case in this situation.It is unknown whether the stomach perforation was caused directly by the device or gastric distension from oxygen insufflation.Based on the information provided, no product returned and the results of our investigation, the root cause was attributed to failure to follow the instructions for use.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6646486
• MDR Text Key: 77735913
• Report Number: 1820334-2017-01406
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-14.0-83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention