MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING

Device Problem Device Sensing Problem (2917)

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

Event Date 05/11/2021

Event Type  malfunction  

Event Description

Device implanted on may 11th.With no reported complications.One day after implant, the monitor stopped showing icp value and showed the message "---" instead.The surgeon decided to replace the valve may 13th.When the explanted catheter was tested in air, the monitor still displayed "---".No complications or medical consequences to the patient's health was reported.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
• Type of Device: ICP MONITORING KIT, PARENCHYMAL TUNNELING
• Manufacturer (Section D): SOPHYSA; r 5ue guy moquêt; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: hanta ranaivoson ; 5 rue guy moquêt; orsay, 91400 ; FR 91400
• MDR Report Key: 12460013
• MDR Text Key: 271040334
• Report Number: 3001587388-2021-21331
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 35 YR