BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS® ADJUSTABLE VALVE / 5 PRESS. 80-400

    MDR report key: 18938758 · Received March 20, 2024

    Report

    Report Number
    3001587388-2024-24076
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 16, 2024
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    UDI-DI
    03760124131291
    PMA / PMN Number
    K141227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THE PRODUCT, THE LABORATORY CARRIED OUT SEVERAL ANALYSES ABOUT THE ASPECT CONTROL AT RECEIPT OF THE VALVE, THE VALVE IS IN POSITION 4, THERE IS A PART OF CATHETER WITH THE INLET CONNECTOR. THERE IS A PRESENCE OF DRIED ORGANIC RESIDUE. ABOUT PRESSURE TEST WITHOUT DECONTAMINATION THE VALVE IS NOT COMPLIANT WITH SOPHYSA'S SPECIFICATION, THE MECHANISM IS BLOCKED IN DUE TO PRESENCE OF DRIED ORGANIC RESIDUE. ABOUT THE ADJUSTEMENT OF THE VALVE, THE TEST IS CONFORM. IN CONCLUSION, THE OBSTRUCTION IS THE CAUSE, THE OBSTRUCTION IS A WELL-KNOWN PHENONEM, WELL DOCUMENTED IN THE ACCOMPANYING DOCUMENTATION.

    Description of Event or Problem · 0

    THE PATIENT IS SUFFERING FROM HYDROCEPHALUS AND HAS BEEN IMPLANTED BY ADJUSTABLE VALVE WITH VENTRICULOPERITONEAL SHUNT SINCE 2016. ON THE (B)(6) 2024, THE PATIENT UNDERWENT A PROCEDURE TO CHANGE THE SHUNT DUE TO HEADACHES. THERE WAS NO OBSTRUCTION, HOWEVER BOTH OF THE VALVE AND THE INTRACEREBRAL CATHETER WERE REPLACED WITH A POLARIS VALVE AND INTRACEREBRAL CATHETER FROM SOPHYSA. THE FOLLOWING DAY, THERE WAS NO IMPROVEMENT IN THE PATIENT'S HEALTH STATE EVEN AFTER SEVERAL VALVE ADJUSTMENTS. ON THE (B)(6) 2024, THE PATIENT RETURNED TO THE OPERATING ROOM TO REPLACE THE POLARIS VALVE DUE TO THE FACT THAT THE STATE OF HEALTH IS NOT IMPROVING. THE VALVE IS MALFUNCTIONING AND OBSTRUCTED AT THE EXTREMITY OF IT AND THE PERITONEAL CATHETER. THE PHYSICIAN REPLACED THE POLARIS VALVE WITH ANOTHER ADJUSTABLE VALVE. THE PATIENT'S CONDITION HAS IMPROVED.

    Description of Event or Problem · 0

    THE PATIENT IS SUFFERING FROM HYDROCEPHALUS AND HAS BEEN IMPLANTED BY ADJUSTABLE VALVE WITH VENTRICULOPERITONEAL SHUNT SINCE 2016. ON THE (B)(6) 2024, THE PATIENT UNDERWENT A PROCEDURE TO CHANGE THE SHUNT DUE TO HEADACHES. THERE WAS NO OBSTRUCTION, HOWEVER BOTH OF THE VALVE AND THE INTRACEREBRAL CATHETER WERE REPLACED WITH A POLARIS VALVE AND INTRACEREBRAL CATHETER FROM SOPHYSA. THE FOLLOWING DAY, THERE WAS NO IMPROVEMENT IN THE PATIENT'S HEALTH STATE EVEN AFTER SEVERAL VALVE ADJUSTEMENTS. ON THE (B)(6) 2024, THE PATIENT RETURNED TO THE OPERATING ROOM TO REPLACE THE POLARIS VALVE DUE TO THE FACT THAT THE STATE OF HEALTH IS NOT IMPROVING. THE VALVE IS MALFUNCTIONING AND OBSTRUCTED AT THE EXTREMITY OF IT AND THE PERITONEAL CATHETER. THE PHYSICIAN REPLACED THE POLARIS VALVE WITH ANOTHER ADJUSTABLE VALVE. THE PATIENT'S CONDITION HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535716 POLARIS® ADJUSTABLE VALVE / 5 PRESS. 80-400 SPV400 JXG SOPHYSA SPV400 306395 03760124131291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other