MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	44420
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product testing is in progress.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the flexibility of the valve was not good during pre-operative testing.According to the report, when the surgeon implanted the valve and tested again, it was determined the valve was not draining.Reportedly, the valve was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.The valve met the requirements for reflux, preimplantation, and leak testing.However, the device did not meet the requirements for pressure-flow testing.There was proteinaceous debris observed within the interior 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.¿ approximately 23.5 cm of the lumbar catheter was returned.It met the requirements for patency and leak testing.Proteinaceous debris was observed on the interior and exterior of the catheter.The peritoneal catheter was returned in two pieces, one measuring 70 cm and one piece measuring 3.5 cm, a total of 73.5 cm.The piece measuring 3.5 cm was not patent.Proteinaceous debris was observed within the interior and exterior of the catheter.The device did not meet the requirements for leak testing due to a tear was observed approximately 3.5 cm from the distal end.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ the catheter also met all of the requirements for the tensile strength and ultimate elongation tests.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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6726355
• Report Number: 2021898-2017-00390
• Device Sequence Number: 19106342
• Product Code: JXG
• UDI-Device Identifier: 00643169010796
• UDI-Public: 00643169010796
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2017

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: 12/31/2021
• Device Catalogue Number: 44420
• Device Lot Number: E24466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 09/06/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/29/2017; 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1