MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	9040 E
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
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 no cerebrospinal fluid (csf) flowed into the reservoir when the catheter and valve were implanted.The surgeon suspected the valve was faulty/spoilt and replaced the valve.It was unknown if any symptoms were associated with the event.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for reflux, leak, and pre-implantation testing.However it did not meet the requirements for pressure-flow 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 (ifu) that accompany the device indicate 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.¿ all valves are 100% tested at the time of manufacture.Approximately 5.5 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 in two pieces, one measuring 1 cm and the other 89 cm.The both edges appear jagged.It is unknown how or when this damage occurred.The returned segments were patent and passed leak testing when tested individually.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.¿ all catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that no information regarding any external/environmental/patient factors that may have led to the event was provided.The event was considered resolved.

• Brand Name: CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, 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: 7339074
• Report Number: 2021898-2018-00144
• Device Sequence Number: 16360544
• Product Code: JXG
• UDI-Device Identifier: 00643169466340
• UDI-Public: 00643169466340
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K831678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 04/30/2020
• Device Model Number: 9040 E
• Device Catalogue Number: 9040 E
• Device Lot Number: D80251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR