MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE SPV

Model Number SPV

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problem Hydrocephalus (3272)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Pending device analysis.A follow-up report will be sent when the analysis is completed.

Event Description

Valve implanted on (b)(6) 2021.An obstruction was suspected on (b)(6) 2021, the valve was replaced.

Event Description

Valve implanted on (b)(6) 2021.An obstruction was suspected on (b)(6) 2021, the valve was replaced.

Manufacturer Narrative

The device records show no history of non conformities nor dergoation during manufacturing.It was returned dried up, relatively clean and not visibly damaged.The valve was in position n°1 with 2 pieces of catheter, one linked to the entry connector and one to the exit.Few blood stains on the interior of the catheter.These 2 catheters were connected by suture.Some residues were visible on the valve.Depth analysis was performed for in lab conditions; obstruction control was performed with air and alcohol; both flow normally inside the device leakage control was performed with air and alcohol: no leakage found.Adjustment control was performed; tests were conforming with no anomaly pressure control was performed and results were stable and within specifications the returned valve was within specification based on the tests performed.The reported probelm couldnt be reproduced nor confirmed.

• Brand Name: POLARIS ADJUSTABLE VALVE SPV
• Type of Device: POLARIS ADJUSTABLE VALVE SPV
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquêt; orsay, 91400 ; FR 91400
• MDR Report Key: 11415541
• MDR Text Key: 238664116
• Report Number: 3001587388-2021-21093
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPV
• Device Catalogue Number: SPV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR