MAUDE Adverse Event Report: NATUS NEURO INCORPORATED VTUN; CAMINO FLEX TUNNELED VENTRICULAR CATHETER

Model Number	VTUN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Dhr review completed and found no anomalies.
Event or Problem Description
Surgical delay due to failed catheter.

• Brand Name: VTUN
• Common Device Name: CAMINO FLEX TUNNELED VENTRICULAR CATHETER
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8533469
• Report Number: 3010611950-2019-00022
• Device Sequence Number: 19198891
• Product Code: GWM
• UDI-Device Identifier: 10381780250395
• UDI-Public: 10381780250395
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133754
• 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): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTUN
• Device Catalogue Number: VTUN
• Device Lot Number: 0197754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 04/19/2019
• 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
• Patient Age: 21 YR