MAUDE Adverse Event Report: COOK INC UNKNOWN; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

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

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.(b)(4).

Event Description

Anis s.Baraka.M.D., et al: tension pneumothorax complicating jet ventilation via cook airway exchange catheter anesthesiology 1999; 91:557-8.The above referenced journal article alleged that a (b)(6) yr-old male patient weighing (b)(6) kg was scheduled for laparoscopic cholecystectomy.The patient had no preoperative cardiac or respiratory problems, and results of his chest radiograph were normal.Anesthesia was induced using thiopentone and fentanyl, and paralysis was induced using 0.1 mg and vecuronium.Laryngoscopy using a mac3 blade only visualized the tip of the epiglottis.Glottic visualization was improved by cephalad, backward and right displacement of the thyroid cartilage.However, the glottic view was still limited, and thus the trachea was intubated using a 6 id oral endotracheal cuffed tube.Because of the patient's body weight, it was decided that the tube be changed to a larger size, using a cook airway exchange catheter.The exchange catheter, with an internal diameter of 3 nun, was inserted into the tracheal tube and advanced until resistance was felt.This was interpreted as the carina.A high-pressure (50 pounds per square inch) oxygen source with a hand-controlled interrupter valve was connected to the proximal end of the exchange catheter vfu a her-lock adapter.Jet ventilation, consisting of 1-s bursts followed by 2 or 3 s of exhalation, was started.This resulted in visible inflation of the right chest but incomplete delation.After only three jet pulses, cardiac asystole (isoelectric electrocardiograph) was noted.The development of tension pneumothorax was considered.The exchange catheter was withdrawn, and ventilation via the endotracheal tube and cardiopulmonary resuscitation were initiated.Chest auscultation revealed decreased air entry to the right lung.Needle thoracoscopy resulted in an audible escape of air was followed by restoration of sinus rhythm.Cardiac arrest lasted 150 s.A right chest tube was inserted.Because of this complication, anesthesia and controlled ventilation were maintained via the original endotracheal tube throughout surgery.The patient recovered without complication.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, instructions for use (ifu), manufacturing instructions, quality control, specifications, and trends was conducted during the investigation.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 lot number of the device is not known, accordingly a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: UNKNOWN
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6095696
• MDR Text Key: 59715668
• Report Number: 1820334-2016-01285
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• 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): Life Threatening
• Patient Age: 45 YR
• Patient Weight: 90