BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY (R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 5409889 · Received August 30, 2004

    Report

    Report Number
    3001587388-2004-00014
    Event Type
    Other
    Date Received
    August 30, 2004
    Date of Event
    June 4, 2004
    Report Date
    August 30, 2004
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE RETURNED DRY. PENDING FOR TEST RESULTS. INTERNAL COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 1

    VALVE RETURNED DRY WITH NO DIFFICULTY TO FLUSH AIR OR WATER. ANALYSIS CONFIRMED THE DAMAGE OF THE VALVE, PROBABLY DUE TO A HIGH PRESSURE OPERATED WHEN FLUSHING THE VALVE WITH SALINE. THE DHR INDICATES THE CONFORMITY OF THE VALVE DURING THE FINAL ACCEPTANCE CHECKINGS. THE INSTRUCTION FOR USE JOINT WITH EACH SOPHYSA MEDICAL DEVICE SET OUT SPECIFIC WARNINGS NOTING FIRST THAT SALINE IS PROHIBITED FOR PATENCY TEST AND SECOND USING A SYRINGE SMALLER THAN 10 CC COULD PROVIDE HIGH PRESSURE INADAPTED FOR THE DEVICE. SO NO CORRECTION ACTION WILL BE DONE. INTERNAL COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2004, THIS SM8 SOPHY ADJUSTABLE PRESSURE VALVE WAS CONNECTED TO THE CATHETER BEFORE IMPLANTATION. IN ORDER TO CONFIRM THE SHUNT PATENCY, THE NEUROSURGEON TRIED TO INJECT SALINE WITHOUT RESULT. HE THOUGHT THE VALVE OCCLUDED DURING THAT PROCEDURE. THEREFORE, THE NEUROSURGEON DIDN'T IMPLANT THE DEVICE. TROUBLE WAS SOLVED BY USING ANOTHER VALVE. NO INJURY WAS FOUND TO THE PATIENT DUE TO THE VALVE OCCLUSION.

    Description of Event or Problem · 1

    ON (B)(6) 2004, THIS SM8 SOPHY ADJUSTABLE PRESSURE VALVE WAS CONNECTED TO THE CATHETER BEFORE IMPLANTATION. IN ORDER TO CONFIRM THE SHUNT PATENCY, THE NEUROSURGEON TRIED TO INJECT SALINE WITHOUT RESULT. HE THOUGHT THE VALVE OCCLUDED DURING THAT PROCEDURE. THEREFORE, THE NEUROSURGEON DIDN'T IMPLANT THE DEVICE. TROUBLE WAS SOLVED BY USING ANOTHER VALVE. NO INJURY WAS FOUND TO THE PATIENT DUE TO THE VALVE OCCLUSION. VALVE RETURNED DRY WITH NO DIFFICULT TO FLUSH AIR OR WATER. ANALYSIS CONFIRMED THE DAMAGE OF THE VALVE, PROBABLY DUE TO A HIGH PRESSURE OPERATED WHEN FLUSHING THE VALVE WITH SALINE. THE DHR INDICATES THE CONFORMITY OF THE VALVE DURING THE FINAL ACCEPTANCE CHECKINGS. THE INSTRUCTION FOR USE JOINT WITH EACH SOPHYSA MEDICAL DEVICE SET OUT SPECIFIC WARNINGS NOTING FIRST THAT SALINE IS PROHIBITED FOR PATENCY TEST AND SECOND USING A SYRINGE SMALLER THAN 10 CC COULD PROVIDE HIGH PRESSURE INADAPTED FOR THE DEVICE. SO NO CORRECTION ACTION WILL BE DONE. INTERNAL COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY (R) ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEMS & COMPONENTS JXG SOPHYSA SOPHY (R) VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK