MAUDE Adverse Event Report: SOPHYSA SOPHY; SOPHYSA ADJUSTABLE VALVE

Model Number SM8

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problem Hydrocephalus (3272)

Event Date 09/06/2016

Event Type  malfunction  

Event Description

Suspision of chronic hypodrainage, despite the valve being in the low position.The valve had to be explanted.

Manufacturer Narrative

The marks observed on the inlet connector lead us to suspect the use of metallic pliers during the manipulation of the valve.The use of such pliers is inadvisable because it can cause a loosening of the connector, leading to the uncalibration of the valve.The instruction for use of the sm8 valve contains a precaution against the use of metallic pliers.

Event Description

Suspicion of chronic hypodrainage, despite the valve being in the low position.The valve had to be explanted.

• Brand Name: SOPHY
• Type of Device: SOPHYSA ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: jean-christophe audras ; 5 rue guy moquet; orsay, 91400 ; FR 91400 ; 3169353500
• MDR Report Key: 6026372
• MDR Text Key: 57315938
• Report Number: 3001587388-2016-16395
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 03760124131093
• UDI-Public: 3760124131093
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2017
• Device Model Number: SM8
• Device Catalogue Number: SM8
• Device Lot Number: Z0115
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR