BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA

    MDR report key: 18516147 · Received January 16, 2024

    Report

    Report Number
    2020394-2023-01393
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 21, 2023
    Report Date
    March 13, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    UDI-DI
    00801741090813
    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 BALLOON CATHETER WAS RETURNED FOR EVALUATION. FIBER DISTURBANCE WAS OBSERVED ON THE BALLOON CATHETER. NO OTHER ANOMALIES WERE NOTED DURING THE VISUAL EVALUATION. ON THE FUNCTIONAL TESTING, THE BALLOON WAS INFLATED WITH AN IN-HOUSE PRESTO INFLATION DEVICE AND WATER WAS LEAKING FROM THE BALLOON NEAR TO THE DISTAL TIP. FURTHER, UNDER MICROSCOPIC OBSERVATIONS, A PIN-HOLE BALLOON RUPTURED. NO OTHER FUNCTIONAL TESTING. THREE RADIOGRAPHIC IMAGE WAS REVIEWED. THE INITIAL PHOTO SHOWS A BALLOON THAT HAS BEEN REMOVED AND IS DEFLATED. NO VISIBLE DEFECT IS NOTED. THE SECOND IMAGE SHOWS AN OCCLUDED ILIAC VEIN. THE THIRD IMAGE IS A SUBTRACTED IMAGE OF THE STENTED ILIAC VEINS AND THE FINAL IMAGE SHOWS THE STENTS IN PLANE FILM. NO OTHER ANOMALIES. AS NO OBJECTIVE EVIDENCE FOR REPORTED ANOMALIES NOTED DURING THE IMAGE REVIEW, HOWEVER ON THE VISUAL OBSERVATIONS ON RETURNED CATHETER, FIBER DISTURBANCE WAS OBSERVED AND MICROSCOPIC OBSERVATIONS CONFIRM THE EVIDENCE OF A PIN-HOLE BALLOON RUPTURE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BALLOON RUPTURE AND IDENTIFIED FIBER DISTURBANCE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE AND IDENTIFIED FIBER DISTURBANCE 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. 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.

    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 RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTOS AND IMAGES WERE PROVIDED FOR REVIEW. 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 A VALVULOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY POPPED. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853114 VIDA BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93NG0006 00801741090813

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown