BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS GOLD

    MDR report key: 19556287 · Received June 18, 2024

    Report

    Report Number
    2020394-2024-00828
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 1, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    00801741060755
    PMA / PMN Number
    K181323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    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 WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 03/2027) H11: SECTION A THROUGH F: THE INFORMATION PROVIDE 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: THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE NO LONGER REPORTABLE. SINCE AN INITIAL MDR WAS SUBMITTED, THEREFORE, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. H10: D4 (EXPIRATION DATE: 03/2027), G3. 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 PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SHIPPING PACKAGE WAS ALLEGEDLY FOLDED IN HALF AND THE PRODUCT WAS ALLEGEDLY FOUND TO BE FOLDED AND DAMAGED AS WELL. IT WAS FURTHER REPORTED THAT THE PRODUCT PACKAGE WAS ALLEGEDLY NOT SEALED SHUT. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SHIPPING PACKAGE WAS ALLEGEDLY FOLDED IN HALF AND THE PRODUCT WAS ALLEGEDLY FOUND TO BE FOLDED AND DAMAGED AS WELL. IT WAS FURTHER REPORTED THAT THE PRODUCT PACKAGE WAS ALLEGEDLY NOT SEALED SHUT. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331609 ATLAS GOLD PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93QJ0136 00801741060755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown