MAUDE Adverse Event Report: SOPHYSA SOPHYSA; KIT PRESSIO® POUR MONITORING DE PIC, PARENCHYMATEUX TUNNELLISABLE

Model Number PSO-PT

Device Problem Device Sensing Problem (2917)

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

Event Date 12/29/2021

Event Type  malfunction  

Event Description

Icp monitoring device implanted to a pediatric patient on (b)(6) 2021.Surgeon reported no anomaly during initial surgery.Zeroing procedure to calibrate the device was successful.Four hours after surgery, the monitor displayed error "e001".The surgeon stated that device was neither damaged nor pulled.However, device was explanted and replaced to continue monitoring.No medical consequences on the patient were reported.

Manufacturer Narrative

Elongation traces were found on the monitoring device (pa tube), which was 30mm superior to a normal length.This elongation would likely cause a breakage to the electric micro wire.This effect is most likely due to a traction that the device underwent during implantation (by user).

• Brand Name: SOPHYSA
• Type of Device: KIT PRESSIO® POUR MONITORING DE PIC, PARENCHYMATEUX TUNNELLISABLE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; temis; rue sophie germain; besançon, ; FR
• Manufacturer Contact: marion prudhomme ; temis; rue sophie germain; besançon, 25000 ; FR 25000
• MDR Report Key: 13962465
• MDR Text Key: 289337331
• Report Number: 3001587388-2022-22022
• 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: Replace
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSO-PT
• Device Catalogue Number: PSO-PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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: 5 YR
• Patient Sex: Male