MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELLING; ICP MONITORING CATHETER

Model Number PSO-VT

Device Problems Incorrect Measurement (1383); Device Sensing Problem (2917)

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

Event Date 01/06/2022

Event Type  malfunction  

Event Description

The surgeon zeroed the device prior to implantation.The calibrated device was implanted on (b)(6) 2022.One day after implantation, the monitor displayed 85 mmhg, which led the surgeon to conduct an examination on the patient.The results showed the icp couldn't be as high as 85mmhg.The device was explanted on (b)(6) 2022.No medical consequences resulted from the incident.

Manufacturer Narrative

The catheter in return does not comply with our specifications, the presence of a micro-tear in the silicone on the edge of the capsule led to mechanical stress at the sensor level with a resulting increase in pressure.

Event Description

One day after catheter implantation, 85 mmhg was displayed on the monitor.The surgeon conducted various examinations on the patient, and the results showed that the patient's intracranial pressure could not be so high.Practician checked the catheter and the value was 67 mmhg.

• Brand Name: PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELLING
• Type of Device: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; 5 rue guy moquet; rue sophie germain; orsay, 91400 ; FR 91400
• MDR Report Key: 13947390
• MDR Text Key: 290454269
• Report Number: 3001587388-2022-22110
• Device Sequence Number: 1
• Product Code: GWM
• 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,User Facility
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• 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): Other
• Patient Age: 44 YR
• Patient Sex: Female