BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA

    MDR report key: 20159884 · Received September 6, 2024

    Report

    Report Number
    2020394-2024-01387
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 13, 2024
    Report Date
    December 16, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE VIDA DEVICE WAS RETURNED FOR EVALUATION. AN IN-HOUSE PRESTO INFLATION DEVICE WAS USED TO INFLATE THE BALLOON, AND WATER WAS NOTED TO BE STREAMING AT THE PROXIMAL END OF THE BALLOON. NO FURTHER TESTING PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL RUPTURE AS WATER WAS NOTED LEAKING FROM THE BALLOON. A DEFINITIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 01/2025). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303329 VIDA BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93NG0070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown