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

Model Number	44420
Medical Device Problem Codes	Fluid/Blood Leak (1250); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
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 drainage was not smooth.It was stated "after the operation, the line was not loosened during the operation, but the water was leaking on the wound." it was suspected that the reservoir was blocked and leaked.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for leak testing.However, it did not meet the requirements for reflux, pressure-flow and preimplantation testing.There was proteinaceous debris noted in the interior and exterior of the device.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux and affecting the flow of fluid through the valve and fluid reflux.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.¿ the 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 caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution 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 47.5 cm of the ventricular catheter was returned.The catheter was patent and met the requirements for leak testing.Approximately 51 cm of the peritoneal catheter was returned.The catheter was patent and met the requirements for leak testing.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.

• 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: 7786162
• Report Number: 2021898-2018-00406
• Device Sequence Number: 1986033
• Product Code: JXG
• UDI-Device Identifier: 00643169975866
• UDI-Public: 00643169975866
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 11/30/2022
• Device Model Number: 44420
• Device Catalogue Number: 44420
• Device Lot Number: E40965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90