MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	25132-1
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned valve was patent.It also met the requirements for siphon, reflux, and pre implantation testing.However, it did not meet the requirements for pressure flow 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 affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device caution that ¿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.¿ the returned valve also did not meet the requirements for leak due to a tear in the top of the delta chamber.It is unknown how or when this damage occurred.The ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.It is also suggested that the valve be placed in a surgically created loose subgaleal pocket.This allows gentle placement of the valve and minimizes handling with surgical tools.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.Approximately 23 cm of the ventricular catheter was returned.Approximately 90 cm of the peritoneal catheter was returned.Both catheters met the requirements for patency and leak testing.Proteinaceous debris was observed on the exterior of the peritoneal catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that during the implant surgery due to aneurysm secondary hydrocephalus, the reservoir of the device was found to be leaking.According to the report, the device was replaced with a new device to complete the surgery and the patient was stable.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6156163
• Report Number: 2021898-2016-00468
• Device Sequence Number: 13465349
• Product Code: JXG
• UDI-Device Identifier: 00643169472761
• UDI-Public: 00643169472761
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/09/2016

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: 10/31/2020
• Device Catalogue Number: 25132-1
• Device Lot Number: E03695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR