MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CODMAN EVD 1.9MM ID CATHETER SET; N/A

Model Number	821739
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference (b)(4).Investigation of evd at hospital shows no leak was noted on the evd set and no disconnection had occured.Waiting for return of device.
Event or Problem Description
Air found in patient's ventricles after inserting evd catheter.

• Brand Name: CODMAN EVD 1.9MM ID CATHETER SET
• Common Device Name: N/A
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8287527
• Report Number: 3010611950-2019-00003
• Device Sequence Number: 16679627
• Product Code: JXG
• UDI-Device Identifier: 10886704040965
• UDI-Public: 10886704040965
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: Health Professional
• Device Model Number: 821739
• Device Catalogue Number: 821739
• Device Lot Number: HM1504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/29/2019
• 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