MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICT MONITORING KIT, VENTRICULAR TUNNELING; PSO-VT

Catalog Number PSO-VT

Device Problems Fluid/Blood Leak (1250); Arcing (2583)

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

Event Date 05/27/2023

Event Type  malfunction  

Event Description

At 0:15 on november 17, the patient underwent right transtemporal lobe cerebral hematoma evacuation + right partial temporal bone resection + right intracranial pressure monitoring electrode implantation under general anesthesia.After the operation, the patient was admitted to gicu, and a drainage tube was placed in the head incision.On november 22, the responsible nurse found that there was fluid leakage in the drainage tube, which resulted in poor drainage.

• Brand Name: PRESSIO® ICT MONITORING KIT, VENTRICULAR TUNNELING
• Type of Device: PSO-VT
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besançon 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; rue sophie germain; besançon 25000 ; FR 25000
• MDR Report Key: 18510926
• MDR Text Key: 333335668
• Report Number: 3001587388-2023-23490
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PSO-VT
• Device Lot Number: 22C01867
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR