MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-CONTOUR SHUNT KIT, ULTRA SMALL, LOW PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	22011 L
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
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 the valve was ¿incompressible when it will be installed¿ because liquid did not flow during testing prior to implant.The valve was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that clarified the previous report of "incompressible when it will be installed" as when the surgeon tested the flow of the vp shunt during the operation, they found that fluid cannot flow through the product.
Additional Manufacturer Narrative
The returned valve was patent and it met all of the requirements for the leakage, reflux, pressure-flow, and preimplantation tests.Therefore, the conditions of the complaint could not be duplicated by laboratory personnel.Proteinaceous debris was observed 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.¿ all valves are 100% tested at the time of manufacture.Approximately 90 cm of the peritoneal catheter was returned.The returned catheter was patent and met the requirements for leak testing.Approximately 23.5 cm of the ventricular catheter was returned.The returned catheter was patent and met the requirements for 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-CONTOUR SHUNT KIT, ULTRA SMALL, LOW PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7020690
• Report Number: 2021898-2017-00570
• Device Sequence Number: 1184235
• Product Code: JXG
• UDI-Device Identifier: 00643169467125
• UDI-Public: 00643169467125
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K792007
• 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,Followup
• Report Date (Section B): 04/11/2018

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: 06/30/2021
• Device Model Number: 22011 L
• Device Catalogue Number: 22011 L
• Device Lot Number: E15822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 03/22/2018; 04/11/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 03/23/2018; 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO