MAUDE Adverse Event Report: SOPHSYA PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING

Model Number PSO-VT

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2023

Event Type  malfunction  

Event Description

The machine showed e001 after the catheter was implanted for 24hours.

Manufacturer Narrative

Analysis: soiled catheter with orange-red deposits (blood) in the drainage holes and in a large part of the central channel.A suture still attached to the silicone tube.A micro-thread (connection between sensor and micro-cable) under the silicone capsule appears broken at the edge of the capsule.Conclusion: the return catheter is not compliant, with a break under the silicone of one of the micro-wires connecting the micro-cable to one of the sensor pads causing error e001.

Event Description

The machine showed e001 after the catheter was implanted for 24 hours.

• Brand Name: PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING
• Type of Device: PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING
• Manufacturer (Section D): SOPHSYA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 18208260
• MDR Text Key: 328964968
• Report Number: 3001587388-2023-23458
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)230303(17)280101
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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 Sex: Female