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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT; PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
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SOPHYSA PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT; PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT Back to Search Results
Model Number PSO-PBT
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device has been received, the analysis in ongoing.A follow-up report will be sent with the results of analysis of the returned device.
 
Event Description
During implantation, the catheter is defective: error message e002 (dongle memory failure) and then e001 (zero impossible) while the patient was immobile.With a 2nd monitor, the zero was accepted with multiple trials but it showed negative value in the head of the patient.The next catheter worked well.
 
Manufacturer Narrative
Our experts performed a visual inspection and a functional check.The visual inspection did not show any defect.When connecting the catheter to the monitor, a value of -40mmhg is displayed.The zero of the catheter has been erased and a new zero procedure is carried out without difficulty.The catheter has been tested for 14 days the zero remains very stable.The offset of -40mmhg appears when a mechanical stress (in this case 40mmhg) is exerted on the sensor prior to installation.Following zero, the stress was released.Causing an offset of -40 mmhg.As a result, the issue is confirmed and the cause is related to the use of the device (mechanical stress on the catheter during the procedure).
 
Event Description
During implantation, the catheter is defective: error message e002 (dongle memory failure) and then e001 (zero impossible) while the patient was immobile.With a 2nd monitor, the zero was accepted with multiple trials but it showed negative value in the head of the patient.The next catheter worked well.
 
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Brand Name
PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
Type of Device
PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
Manufacturer (Section D)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR  91400
MDR Report Key10873793
MDR Text Key219565469
Report Number3001587388-2020-20597
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
PMA/PMN Number
K162108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberPSO-PBT
Device Catalogue NumberPSO-PBT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Date Manufacturer Received10/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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