BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS GOLD

    MDR report key: 19710729 · Received July 10, 2024

    Report

    Report Number
    2020394-2024-01012
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 14, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    00801741060885
    PMA / PMN Number
    K181323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ATLAS GOLD PTA DILATATION CATHETER WAS RECEIVED FOR EVALUATION. DURING VISUAL ANALYSIS, THE CATHETER SHAFT WAS NOTED TO BE SEPARATED FROM THE INNER GUIDEWIRE LUMEN AT THE PROXIMAL GLUE JOINT. FURTHER, THE BALLOON WAS NOTED TO BE DETACHED FROM THE DEVICE AND WAS NOT RETURNED. NO OTHER ANOMALIES WERE NOTED. NO FURTHER FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DEVICE CONDITION. THEREFORE, THE INVESTIGATION REMAINS INCONCLUSIVE FOR THE REPORTED BALLOON RUPTURE AS NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DETACHMENT ISSUE AS THE BALLOON WAS COMPLETELY DETACHED WHICH WAS NOT RETURNED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT AND BALLOON RUPTURE ISSUES 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

    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. (EXPIRATION DATE: 03/2027). 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 WAS ALLEGEDLY RUPTURED AT 20 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY COMPLETELY DETACHED INSIDE THE PATIENT'S LEFT ILIAC VEIN. REPORTEDLY, THE DETACHED COMPONENT WAS REMOVED FROM THE PATIENT BY THROMBECTOMY. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 20 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY COMPLETELY DETACHED INSIDE THE PATIENT'S LEFT ILIAC VEIN. REPORTEDLY, THE DETACHED COMPONENT WAS REMOVED FROM THE PATIENT BY THROMBECTOMY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145402 ATLAS GOLD PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93QJ0101 00801741060885

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male