MAUDE Adverse Event Report: CORPAK MEDSYSTEMS CORTRAK 2 EAS SYSTEM

Catalog Number	20-0950
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned cotrak unit was tested and found to be fully functional.In addition the corview tracings from the returned unit were reviewed.The first tracing starts at 9:33 pm as "out of range" at approximately 27 seconds into the placement the tracing begins and immediately shows the tube veering to the right of the patients midline.The tracing stops at 58 seconds.The second tracing shows the tube veering to the right of the patients midline at approximately 6 seconds into the placement.The tracing continues in a downward direction right of the patients midline.Both tracings are consistent with a right lung placement as shown in the instructions for use.
Event or Problem Description
A nurse was placing a feeding tube on (b)(6) 2016 using cortrak, the patient began to show symptoms of respiratory distress, x-ray indicated the feeding tube was in the right lung indicative of a right lung pneumothorax.Cortrak tube was withdrawn and patient was treated for right lung pneumothorax.Patient stable and expected to recover without further incident.

• Brand Name: CORTRAK 2 EAS SYSTEM
• Common Device Name: CORTRAK 2
• Manufacturer (Section D): CORPAK MEDSYSTEMS; 1001 asbury drive; buffalo grove IL 60089
• MDR Report Key: 6189163
• Report Number: 3009124963-2016-00030
• Device Sequence Number: 359332
• Product Code: KNT
• UDI-Device Identifier: 10815149024698
• UDI-Public: 10815149024698
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/20/2016

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
• Operator of Device: Nurse
• Device Catalogue Number: 20-0950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Weight: 69