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

Catalog Number	25132-5
Medical Device Problem Codes	Break (1069); Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	11/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, reflux, and leak testing.However, it did not meet the requirements for pressure flow and 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 affecting the flow of fluid through the valve.The instructions for use 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.¿ approximately 9.5 cm of the ventricular catheter was returned.It met the requirements for patency and leak testing.The peritoneal catheter was returned in two pieces of lengths 9 cm and 88 cm respectively.Proteinaceous debris was observed within the exterior of the catheter and the tear site appears to be jagged.It is unknown how or when this damage occurred.The returned segments were patent and passed leak testing when tested individually.The catheter met all of the requirements for the tensile strength and ultimate elongation tests.The instructions for use that accompany the device cautions that low tear strength is a characteristic of most unreinforced silicone elastomer materials, and that care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device was implanted in (b)(6) 2015.According to the report, it was found that the flow through the device was poor and when checked, it was determined the peritoneal catheter was broken.Reportedly, the system was removed including the broken parts of the catheter.The system was replaced and the patient was well.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6199679
• Report Number: 2021898-2016-00484
• Device Sequence Number: 623378
• Product Code: JXG
• UDI-Device Identifier: 00613994803672
• UDI-Public: 00613994803672
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 25132-5
• Device Lot Number: D61262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: 11/24/2016
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 28 YR