MAUDE Adverse Event Report: SOPHYSA POLARIS, SPV ADJUSTABLE VALVE; POLARIS SPV ADJUSTABLE VALVE

Model Number SPV

Device Problems Obstruction of Flow (2423); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem Hydrocephalus (3272)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet.Once the evaluation is completed, we will be able to know if the valve was defective or not.

Event Description

The adjustable valve was implanted on (b)(6) 2020 and suspected of being blocked.Indeed, the physician implanted the valve by setting pressure 200 at that time, the flow seemed to be bad.A few days later, the physician tried to change the setting pressure, but it couldn't.The magnet was placed directly through under the fluoroscopy, but it was not changed.The physician decided to explant the valve and to replace it.

Event Description

The adjustable valve was implanted on (b)(6) 2020 and suspected of being blocked.Indeed, the physician implanted the valve by setting pressure 200 at that time, the flow seemed to be bad.A few days later, the physician tried to change the setting pressure, but it couldn't.The magnet was placed directly through under the fluoroscopy, but it was not changed.The physician decided to explant the valve and to replace it.

Manufacturer Narrative

Internal documentation shows that the catheter has been manufactured in accordance with the quality requirements and does not show any performance abnormality or any causality relationship between the reported incident and the suspected device.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 test did not show any abnormality.However, the returned valve was in position 1 while the report mentions a position 200.The functional tests showed a non-conformity in the rotation test in the return state (the device was dry with deposits and dried blood).However, the rotation test after soaking for 24 hours in bleach was conform.As a result, the defect is confirmed but that could have been caused by the drying of the blood after explantation.

• Brand Name: POLARIS, SPV ADJUSTABLE VALVE
• Type of Device: POLARIS SPV ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: viviane payrou ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10481194
• MDR Text Key: 219565069
• Report Number: 3001587388-2020-20140
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031097
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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
• Device Lot Number: G032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female