BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS

    MDR report key: 20115776 · Received September 1, 2024

    Report

    Report Number
    2020394-2024-01321
    Event Type
    Malfunction
    Date Received
    September 1, 2024
    Date of Event
    July 17, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    00801741062469
    PMA / PMN Number
    K120971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 03/2027). H11: D2B (DQY; LIT).

    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: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED ENTRAPMENT OF DEVICE AND UNRAVELED MATERIAL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY CAUGHT ON THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY CAUGHT ON THE STENT. IT WAS FURTHER REPORTED THAT ONE OF THE KEVLAR FIBERS ON THE BALLOON HAD BECOME LOOSE WHICH CAUGHT ON THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080056 ATLAS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFJQ0209 00801741062469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown