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

Catalog Number UNKNOWN

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

Patient Problems Perforation (2001); Pneumothorax (2012)

Event Date 03/15/2011

Event Type  Death  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.(b)(4).

Event Description

"citation: duggan, l., law, a., & murphy, m., (2011) brief review: supplementing oxygen through an airway exchange catheter: efficacy, complications, and recommendations.Canadian journal of anesthesiologists' society doi 10.1007/s12630-011-9488-4 article outlines information obtained from a literature search (undertaken by the authors) to compare efficacy of oxygen supplementation by utilizing airway exchange catheters.The case studies noted 4 patients that experienced complications/adverse events from the use of cook inc.Airway exchange catheters.Details were limited in scope as they were given in table 2 contained in the attached study.Four patients were listed as having received an cook airway exchange catheter.Three patients experienced pneumothorax, one patient experienced gastric perforation related to esophageal misplacement, two of the four patients listed also experienced cardiac arrest, but no patient deaths were reported.Three of the airway exchange catheters were 14fr cook catheters and one was noted to be 19fr.In addition to the patients mentioned in the tabulated data provided in the journal article, an additional event was discussed which involved a (b)(6) male patient who underwent maxillofacial surgery.During the procedure, intermaxillary fixation with elastic traction was utilized.On emergence from anesthesia, an unspecified airway exchange catheter of unknown manufacture was placed through the nasoendotracheal tube.The nasoendotracheal tube was removed, leaving the airway exchange catheter (aec) in place.Additionally, a nasogastric tube was placed through the contralateral nostril.The patient was transferred to the post anesthesia care unit with the aec in place.Jet ventilation or the provision of oxygen at high pressures was not used.Within minutes of arriving at the post anesthesia care unit, the patient complained of back pain, before he deteriorated rapidly into cardiopulmonary arrest.A needle thoracotomy was performed for a tension pneumothorax, but the patient expired.Information has been requested from the (b)(6) coroners office concerning the patient that expired on approximately (b)(6) 2018.Information concerning the manufacturer of the unspecified airway exchange catheter was requested, however, no information has been received to date.

Manufacturer Narrative

Additional information was received on 26jun2018.It was stated that the customer can only provide non-identifying information.There is no indication in the file that an equipment malfunction.The pathologist noted the following cod in his/her post mortem report: ¿severe hypoxic/ischemic encephalopathy secondary to post-operative cardiac arrest.¿ an expert review of the case by an anesthetist was requested by our office.The documents reviewed included the hospital records, coroner¿s report and post mortem report.Their conclusion was a follows: ¿therefore, in my opinion barotrauma in the form of pneumomediastinum / pneumothorax as a complication of the use of an airway exchange catheter was the precipitant cause of his cardiorespiratory collapse that led to death from hypoxic ischemic encephalopathy.¿ these answers are in response to questions sent to the office of the chief coroner of (b)(6) through coroner's public website to obtain additional information needed.The following questions were requested and not answered.Please provide the manufacturer of the airway exchange catheter (aec) referenced in the report? please provide the hospital where the patient was treated? this report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Investigation - evaluation: a review of the instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.The autopsy report of the patient was also not made available to cook.It was reported from the office of the coroner that there was no indication of an equipment malfunction.It was also reported that it is likely barotrauma and pneumothorax arose as a result of complications with the use of the device that eventually lead to the death of the patient.It was not specifically stated that a cook aec was used in this procedure, however based on statements in the article describing cook aecs as the most popular devices and the multiple cited incidents involving a cook aec, this case was treated as though a cook aec was being used when this event occurred.A document review was conducted for airway exchange catheters product codes.There are adequate controls in place to ensure that the device was manufactured to specifications.The lot number of the device was not available, so a review of the complaint history and device history record could not be performed.As stated in the instructions for use, barotrauma and perforation of the bronchi or lung parenchyma are potential adverse events that may occur with use of this device.It was reported that a low pressure oxygen source was used to ventilate, so these problems were not caused by incorrectly using a high pressure oxygen source.The authoring physicians stated in their response that there could be problems experienced using this device for ventilation if a patient is unable to expire the volumes of air delivered through the device.The patient had a nasogastric tube in place, as well as having their jaw wired shut as a result of maxillofacial surgery.Based on this information it is possible the patient was unable to expire an adequate amount of air while the device was in use, leading to trauma.It is also possible that the device was improperly placed in the airway of the patient, leading to barotrauma and eventually death.The appropriate personnel will be notified and we will continue to monitor for similar complaints.Per the results of the risk assessment, no further risk reduction activities are required.

• Brand Name: UNKNOWN
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7448525
• MDR Text Key: 106137975
• Report Number: 1820334-2018-01206
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other