MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT KIT CONTOURED REGULAR, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	9003 E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
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 during surgery, the valve was leaking at the edge of the reservoir.The valve was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux 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.¿ the returned valve also did not meet the requirements for leak testing due to a tear 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, or crushing of components.¿ all valves are 100% tested at the time of manufacture.Approximately 23 cm of the ventricular catheter was returned.It met the requirements for patency and leak testing.Approximately 90 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: CSF-FLOW CONTROL SHUNT KIT CONTOURED REGULAR, MEDIUM PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7063633
• Report Number: 2021898-2017-00605
• Device Sequence Number: 16488534
• Product Code: JXG
• UDI-Device Identifier: 00643169466371
• UDI-Public: 00643169466371
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K841442
• 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
• Report Date (Section B): 02/14/2018

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: 09/30/2020
• Device Model Number: 9003 E
• Device Catalogue Number: 9003 E
• Device Lot Number: E03212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 70