MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE

Model Number	SPV-400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Headache (1880); Hydrocephalus (3272)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to sophysa in-house process, the returned catheter has been analysed by our quality control laboratory and a visual and functional control were performed.The visual tests showed that the valve was in the 4th position, and it was very clean inside.The functional tests did not reveal any anomaly.Indeed, the programming before and after soaking for 24 hours in bleach was correct.The pressures are conform and repeatable.The valve is conform in all points.
Event or Problem Description
Patient underwent surgery 7/23/2020.1.5 weeks post-op, he developed clear low pressure headaches.Attempted adjustment to 400 several times.The patient continued to have headaches.Unsuccessful adjustment.Valve was found in appropriate position.When externalised valve was not adjusting.
Event or Problem Description
Patient underwent surgery (b)(6) 2020.1.5 weeks post-op, she developed clear low pressure headaches.Attempted adjustment to 400 several times.The patient continued to have headaches.Unsuccessful adjustment.Valve was found in approrpiate position.When externalised valve was not adjusting.
Additional Manufacturer Narrative
According to sophysa in-house process, the returned valve has been analysed by our quality control laboratory and a visual and functional controls were performed.The visual tests showed that the valve setting was on position p4, and it was clean inside.The functionnal tests did not reveal any anomaly.Indeed, the programming before and after soaking for 24 hours was correct.The pressure measurement have been tested on every positions of the valve and the pressures are conform and repeatable.As a result, the analysis showed that the valve is conform to its specifications.The event could not be reproduced and the root cause remains unidentified.A possible cause of the event could be a debri inside the valve that could have been eliminated at the hospital during the cleaning process prior to sending the device to the manufacturer.This might have led into setting issue.

• Brand Name: POLARIS ADJUSTABLE VALVE
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10592577
• Report Number: 3001587388-2020-20485
• Device Sequence Number: 373074
• Product Code: JXG
• UDI-Device Identifier: 03760124131291
• UDI-Public: (01)03760124131291(11)191004(17)241001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: No Information
• Device Expiration Date: 10/01/2024
• Device Model Number: SPV-400
• Device Catalogue Number: SPV-400
• Device Lot Number: G042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR