BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE DILATATION BALLOON VALVULOPLASTY CATHERTER

    MDR report key: 3257073 · Received March 27, 2013

    Report

    Report Number
    3009391754-2013-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 27, 2013
    Manufacturer
    LOMA VISTA MEDICAL, INC.
    Product Code
    OZT
    PMA / PMN Number
    K121083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAUSE AND CORRECTIVE ACTIONS: A LEADING CAUSE FOR SLOW DEFLATION TIME IS BALLOON TWISTING IMPARTED ON THE BALLOON DURING THE MANUFACTURING PROCESS. THIS TWISTING, IF PRESENT, CAN LEAD TO A REDUCTION IN THE BALLOON LUMEN CROSS-SECTIONAL AREA AVAILABLE TO DEFLATE THE BALLOON, THEREBY SLOWING DEFLATION TIME.

    Description of Event or Problem · 1

    SLOWER THAN NORMAL BALLOON DEFLATION TIMES OF 10 SECONDS OR GREATER WERE REPORTED AFTER 9 SEPARATE AORTIC VALVULOPLASTY PROCEDURES INVOLVING 9 SEPARATE DEVICES AT 4 DIFFERENT HOSPITALS (1 IN USA HEREIN AND 3 IN EUROPE). THE BALLOON NORMALLY DEFLATES IN LESS THAN 5 SECONDS WHEN USED IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE. AN URGENT DEVICE REMOVAL IS BEING CARRIED OUT TO REDUCE THE POTENTIAL FOR PATIENT ADVERSE EVENTS. AT THE TIME OF THIS REPORT, NO DEVICE USERS HAVE INDICATED THAT ANY ADVERSE EVENTS HAVE OCCURRED AS A RESULT OF THE SLOWER THAN NORMAL DEFLATION TIMES. SOME EVENT DATES ARE NOT KNOWN. THE EVENT DATE REPORTED IN THIS MDR IS THE EARLIEST KNOWN EVENT DATE (SOME EVENT DATES MAY HAVE BEEN EARLIER BUT WERE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127304 TRUE DILATATION BALLOON VALVULOPLASTY CATHERTER BALLOON AORTIC VALVULOPLASTY CATHETER, PRODUCT CODE: OZT OZT LOMA VISTA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1