BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALFAPUMP SYSTEM

    MDR report key: 24853871 · Received April 13, 2026

    Report

    Report Number
    3010817031-2026-00006
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 12, 2026
    Manufacturer
    SEQUANA MEDICAL
    Product Code
    SDQ
    PMA / PMN Number
    P230044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT HAS HAD CONSISTENT BURNING AFTER URINATING. DESCRIBES IT AS LASTING 30-45 MINUTES AFTER URINATING. AS HE IS URINATING FREQUENTLY, THIS IS PRETTY MUCH ALL THE TIME. PATIENT'S QUALITY OF LIFE IS NEGATIVELY AFFECTED. BLOOD NOTED IN URINE, HE DID NOT HAVE BLOOD IN HIS ASCITES PRIOR TO ALFAPUMP PROCEDURE. DOCTOR IS CONCERNED THAT BLADDER CATHETER IS TOO LONG. PLANNING A REINTERVENTION IN NEAR FUTURE TO SHORTEN. MEDICAL DIRECTION AT SEQUANA HAS BEEN IN TOUCH TO ASSIST WITH DECISION MAKING. OPENED BLADDER CATHETER INCISION. CUT BLADDER CATHETER. REMOVED ABOUT 1CM. PLACED NEW CONNECTOR. TEST CYCLED PERFORMED. LATE DROP DOWNS FOUND. ULTRASOUND FOUND SCANT ASCITES IN ABDOMEN. BLADDER CATHETER CONFIRMED WITH CONTRAST. DOCTOR GIVEN OK TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922876 ALFAPUMP SYSTEM ALFAPUMP SDQ SEQUANA MEDICAL 01473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention