BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHYSA CATHETERS

    MDR report key: 5483381 · Received February 2, 2005

    Report

    Report Number
    3001587388-2005-00002
    Event Type
    Other
    Date Received
    February 2, 2005
    Date of Event
    November 30, 2004
    Report Date
    February 2, 2005
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PART OF THE CATHETER TUBE WAS RETURNED FOR ANALYSIS. THE INTERNAL AND EXTERNAL DIAMETER WERE MEASURED PROVING THAT THE CATHETER MEETS ITS DESIGN SPECIFICATIONS. THE DEVICE HISTORY FILE DOESN'T REFLECT ANY MATTER REGISTERED DURING MANUFACTURING. WE CONCLUDE THAT THE CATHETER IS WITHOUT DEFECT. SO, NO CORRECTIVE ACTION WILL BE DONE.

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE NEUROSURGEON ATTEMPTED TO CONNECT PLO6 CATHETER TO A CUSTOMER OWNED CATHETER PASSER BUT HE FAILED. HE THOUGHT THAT THE DIAMETER OF THE PLO6 CATHETER WAS THICKER THAN USUAL. ANOTHER CATHETER WAS USED WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHYSA CATHETERS VENTRICULAR CATHETER JXG SOPHYSA SA VENTRICULAR CATHER WITH LERO RESERVOIR M0318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK