BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    MDR report key: 20704284 · Received November 18, 2024

    Report

    Report Number
    3001587388-2024-24382
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    November 6, 2024
    Report Date
    March 14, 2025
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP1: A CAPA2024-05 HAS BEEN OPENED IN ORDER TO PUT IN PLACE CORRECTIVE ACTION TO PREVENT THE APPARITION OF THIS MISUSE. THE ACTION PLAN IS NOT YET FINISHED. NO FURTHER INVESTIGATION WILL BE MADE SINCE THE ROOT CAUSE HAS BEEN FOUND TO BE RELATED TO MISUSE OF THE DEVICE : TIGHTENING THE BOLD WHEN THE STYLET IS STILL INSIDE THAT PROVOKE THE BREAKAGE OF THE LOCKING CLIP AND PREVENT THE BOLT FROM KEEPING THE CATHETER IN PLACE FOR A CORRECT MONITORING OF THE PATIENT. FOLLOW-UP2: ALL THE INVESTIGATIONS CONFIRMED THAT THE DEFECT WAS IDENTICAL ON BOTH RETURNED DEVICES AND CORRESPONDED TO DEFORMATION AND DAMAGE TO THE CLAMP IN THE BOLT. BASED ON OUR INVESTIGATION RESULTS AND ON PHYSICIANS' FEEDBACK WE CAN DEMONSTRATE THAT COMPLAINTS ARE DUE TO USERS, FROM ONE SPECIFIC CENTER, WHO DID NOT PROPERLY FOLLOW INSTRUCTIONS FOR USE. IN CONCLUSION THE ROOT CAUSE IS : USER ERROR. ACCORDING TO THE FDA'S REQUESTED LABELING CHANGE FOR PRESSIO 2 ICP MONITORING SYSTEM, K162108, THE IFU WILL BE UPDATED TO ADD A STATEMENT IN CATHETER IMPLANTATION SECTION.

    Additional Manufacturer Narrative · 0

    A CAPA2024-05 HAS BEEN OPENED IN ORDER TO PUT IN PLACE CORRECTIVE ACTION TO PREVENT THE APPARITION OF THIS MISUSE. THE ACTION PLAN IS NOT YET FINISHED. NO FURTHER INVESTIGATION WILL BE MADE SINCE THE ROOT CAUSE SEEMS TO BE AS SIMILAR CASES RELATED TO MISUSE OF THE DEVICE : TIGHTENING THE BOLD WHEN THE STYLET IS STILL INSIDE THAT PROVOKE THE BREAKAGE OF THE LOCKING CLIP AND PREVENT THE BOLT FROM KEEPING THE CATHETER IN PLACE FOR A CORRECT MONITORING OF THE PATIENT.

    Additional Manufacturer Narrative · 0

    NO CORRECTIVE OR PREVENTIVE ACTION HAS BEEN TAKEN SINCE WE DON'T KNOW AT WHICH MOMENT THE PROBLEM OCCURS. BUT A SENSIBILIZATION OF ALL THE OPERATOR HAS BEEN MADE. FUTHER ANALYSIS MUST BE PERFORMED TO DETERMINE WHEN THE BOLT HAS BEEN BROKEN (AT THE MANUFACTURING SITE OR AT THE HOSPITAL). THE MANUFACTURER WILL CONTACT THE REPORTER TO INVESTIGATE ON THIS PART. ON THE SAME TIME, THE QUALITY TEAM WILL CONTROL BOLT OF PRESSIO(R) KITS THAT ARE READY TO BE SEND TO CUSTOMER TO SEE IF THERE IS ANY BOLT BROKEN.

    Description of Event or Problem · 0

    THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION. THE CATHETER SLIP OUT THE BOLT AT D17 AFTER IMPLANTATION.

    Description of Event or Problem · 0

    THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION. THE CATHETER SLIP OUT THE BOLT AT D17 AFTER IMPLANTATION.

    Description of Event or Problem · 0

    THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION. THE CATHETER SLIP OUT THE BOLT AT D17 AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620822 PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT ICP AND ICT MONITORING CATHETER GWM SOPHYSA PSO-PBT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other