BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERRANATOR

    MDR report key: 24578629 · Received March 12, 2026

    Report

    Report Number
    24578629
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 17, 2026
    Report Date
    February 26, 2026
    Manufacturer
    CAGENT VASCULAR, LLC
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INFLATION BALLOON WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638167 SERRANATOR CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO CAGENT VASCULAR, LLC FGS-0492-40040 FA25101403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other