BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA

    MDR report key: 12546198 · Received September 29, 2021

    Report

    Report Number
    12546198
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 9, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BALLOON CATHETER WOULD NOT MAINTAIN PRESSURE DURING INFLATION WHILE IN THE PATIENT. THE BALLOON WAS REMOVED AND REPLACED WITHOUT INCIDENT OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446102 VIDA PULMONARY (PULMONIC) VALVULOPLASTY CATHETERS/PERCUTANEOUS VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. VDA100202 93UD0063

    Patients

    Seq Age Sex Outcome Treatment
    1