BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 6173469 · Received December 14, 2016

    Report

    Report Number
    3001587388-2016-16494
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    October 31, 2016
    Report Date
    January 2, 2017
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K013488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETERS ARE DELIVERED WITH A RIGID STYLET. THIS TYPE OF TEAR COULD BE EXPLAINED BY AN EXCESSIVE TRACTION APPLIED TO THE TIP OF THE CATHETER USING THE STYLET. THE TRACEABILITY PERFORMED ON THE LOT NUMBER OF THE CATHETER DOES NOT SHOW ANY ABNORMALITY. THE TUBING USED FOR MANUFACTURING THESE CATHETERS IS COMPLIANT TO ITS SPECIFICATIONS IN TERMS OF TEARING AND LENGTHENING.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A PATIENT UNDERWENT SURGERY FOR THE IMPLANTATION OF A VALVE WITH A STRAIGHT VENTRICULAR CATHETER. UPON IMPLANTING THE CATHETER, THE SURGEON NOTED THAT THE CATHETER WAS DAMAGED, WITH A CRACK IN THE LOWER TIP WHICH WOULD BE LODGED IN THE VENTRICLE. THEREFORE, HE DEEMED NECESSARY TO REPLACE THE CATHETER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A PATIENT UNDERWENT SURGERY FOR THE IMPLANTATION OF A VALVE WITH A STRAIGHT VENTRICULAR CATHETER. UPON IMPLANTING THE CATHETER, THE SURGEON NOTED THAT THE CATHETER WAS DAMAGED, WITH A CRACK IN THE LOWER TIP WHICH WOULD BE LODGED IN THE VENTRICLE. THEREFORE, HE DEEMED NECESSARY TO REPLACE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824987 SOPHYSA CATHETER, VENTRICULAR, STRAIGHT JXG SOPHYSA BO19-10 C0738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other