MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	25132-5
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2018
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 clinician implanted the valve during the procedure, they checked it to determine if it was allowing flow of cerebrospinal fluid (csf).After palpating the valve, the clinician decided there was no csf flow.The valve was replaced.There were no symptoms or complications associated with the event.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, and reflux testing.The valve did not meet the 20.4 ml/hr requirement of the pressure flow test.However, it passed the 46.8 and 5.5 ml/hr pressure flow and the pre-implantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open, which could affect the flow of fluid through the valve.The ¿warning and precaution¿ section of the ¿instructions for use (ifu)¿ that accompanies the device cautions, ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ no ventricular catheter or peritoneal catheter was returned.However, small amounts of catheter were sutured to the inlet and outlet of the valve, but there was not the required length to test for patency or leak.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7781362
• Report Number: 2021898-2018-00400
• Device Sequence Number: 13801006
• Product Code: JXG
• UDI-Device Identifier: 00643169466418
• UDI-Public: 00643169466418
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 12/31/2022
• Device Model Number: 25132-5
• Device Catalogue Number: 25132-5
• Device Lot Number: E41973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1