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 doing an intraventicular abdominal shunt and during the process of the pre-operative water test, the valve was found to be leaking.
Additional Manufacturer Narrative
The returned valve did not meet the requirements for leak testing due to a large tear observed in the top of the proximal occluder.It is unknown how or when this damage occurred.Therefore, the patency, siphon, reflux, pressure-flow and preimplantation testing were precluded due to this damage.The instructions for use that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ all valves are 100% tested at the time of manufacture.Approximately 91 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: 7554424
• Report Number: 2021898-2018-00271
• Device Sequence Number: 19147709
• 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: 07/31/2022
• Device Model Number: 96823
• Device Catalogue Number: 96823
• Device Lot Number: E39712
• 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: 08/08/2018
• 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