MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE BURR-HOLE RESERVOIR SIPHON X

Model Number POLARIS

Device Problem Decrease in Pressure (1490)

Patient Problem No Code Available (3191)

Event Date 09/02/2013

Event Type  Injury  

Event Description

Valve implanted in (b)(6) 2013, now clinically overdrainage, valve pressure position at 200 mm h20, intraop testing of the valve showed a pressure of 80 mm h2o explantation.

Manufacturer Narrative

The suspected valve has been received and analyzed by our quality control laboratory.According to the device inspection results, before and after cleaning, the valve did not meet all of its functional specifications and the difficulty to undergo the highest pressure setting procedure has been duplicated.Indeed, 2/3 of the measured values were outliers.However, no abnormal valve behaviour was observed when the pressure setting procedure was operated in laboratory environment to adjust the valve on the lower pressure positions and back to the higher pressure position.Regarding the closing pressure on high pressure setting, the valve meets its requirements specifications with a conforming hysteresis from the operating pressure.The main explanations for this discalibration might be the post hemorrhagic csf which could have modified the ball-in-cone mechanism and the surface of the rub ball and its metallic seat.

• Brand Name: POLARIS ADJUSTABLE VALVE BURR-HOLE RESERVOIR SIPHON X
• Type of Device: POLARIS ADJUSTABLE VALVE BURR-HOLE RESE
• Manufacturer (Section D): SOPHYSA; orsay ; FR
• Manufacturer Contact: 5, rue guy moquet; orsay cedex 91400 ; 69353500
• MDR Report Key: 3581297
• MDR Text Key: 4059755
• Report Number: 3001587388-2013-00322
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: POLARIS
• Device Catalogue Number: SPVB-SX
• Device Lot Number: Z0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1