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

Model Number	96823
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
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 the physician was to perform a ventriculoperitoneal shunt; however, during the pre-operative water testing, they found that the valve was leaking.
Additional Manufacturer Narrative
The returned valve was patent, and met the requirements for siphon, pressure-flow, preimplantation, and leak testing.However, it did not meet the requirements for reflux testing.There was debris noted 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 and resulting in fluid reflux.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.¿ all valves are 100% tested at the time of manufacture.Approximately 7.5 cm of the ventricular catheter was returned.It met the requirements for patency and leak testing.Approximately 90 cm of the peritoneal catheter was returned.It met the requirements for patency and 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.

• Brand Name: DELTA SHUNT ASSEMBLY WITH BIOGLIDE, 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: 7555114
• Report Number: 2021898-2018-00275
• Device Sequence Number: 11082062
• Product Code: JXG
• UDI-Device Identifier: 00643169483170
• UDI-Public: 00643169483170
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951258
• 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): 08/10/2018

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: 04/30/2021
• Device Model Number: 96823
• Device Catalogue Number: 96823
• Device Lot Number: E15056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1