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

Catalog Number	42365
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, and pre-implantation testing.However, it did not meet the requirements for pressure-flow testing.Proteinaceous debris was noted within the interior and exterior of 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¿.The returned valve also did not meet the requirements for leak testing due to multiple tears observed in the top of the reservoir.It is unknown how or when this damage occurred.The ifu that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also cautions that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ approximately 6.5 cm of the ventricular catheter was returned.Approximately 89 cm of the peritoneal catheter was returned.Both catheters met the requirements for patency and leak testing.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 obstructed intra-operatively.According to the report, another device was used to completed the procedure.Reportedly, there was no injury to the patient.

• Brand Name: STRATA NSC VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6268074
• Report Number: 2021898-2017-00018
• Device Sequence Number: 13665404
• Product Code: JXG
• UDI-Device Identifier: 00643169466111
• UDI-Public: 00643169466111
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K033850
• 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
• Report Date (Section B): 12/22/2016

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: 02/28/2021
• Device Catalogue Number: 42365
• Device Lot Number: E10787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1