MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY RIVULET VENTRICULAR CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	41701
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after the stylet was removed from the catheter, it was unable to be reinserted.It was questioned if the catheter was blocked.The stylet that was packaged with the catheter was the same stylet being used.A different catheter was used to complete the procedure with no issues.
Additional Manufacturer Narrative
Only the ventricular catheter was returned.The catheter was patent and met the requirements for leak testing.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RIVULET VENTRICULAR CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7553595
• Report Number: 2021898-2018-00267
• Device Sequence Number: 16187622
• Product Code: JXG
• UDI-Device Identifier: 00613994480446
• UDI-Public: 00613994480446
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K792007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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 Expiration Date: 04/30/2019
• Device Model Number: 41701
• Device Catalogue Number: 41701
• Device Lot Number: E32992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/08/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/26/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1