BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS GOLD

    MDR report key: 18280654 · Received December 7, 2023

    Report

    Report Number
    2020394-2023-01152
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    August 1, 2023
    Report Date
    July 16, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    UDI-DI
    00801741060762
    PMA / PMN Number
    K181323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON 8-JULY-2024 FROM MDR DATA SYSTEMS TEAM, (B)(6), INDICATING THAT THE INFORMATION (SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D) OF THE PREVIOUSLY SUBMITTED FDA FORM 3500A, WAS INCORRECT AND A REQUEST WAS MADE TO SUBMIT SUPPLEMENTAL REPORT(S) WITH THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS IN THE "UNIQUE DEVICE IDENTIFIER (UDI) #" FIELDS. THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THAT REQUEST. H11: D2: MEDICAL DEVICE TYPE-DQY; LIT. D4: MEDICAL DEVICE EXPIRATION DATE- 10/11/2025. D4: UDI- (B)(6). H4: DEVICE MANUFACTURE DATE- 10/11/2022. G4: K122984; K181323.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE ATLAS GOLD PTA DILATATION CATHETER WAS RECEIVED FOR EVALUATION. DURING VISUAL EVALUATION, KINKS AND TWISTING WERE NOTED TO THE CATHETER SHAFT. A KINK WAS ALSO NOTED AT THE BALLOON'S PROXIMAL END, AND A SPLIT WAS OBSERVED TO THE BALLOON'S DISTAL TIP. NO ANOMALIES TO THE LUERS/Y-BODY. DURING FUNCTIONAL EVALUATION, AN IN-HOUSE PRESTO INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO 18 ATM. THE BALLOON WAS INFLATED AND MAINTAINED PRESSURE, THE BALLOON WAS THEN DEFLATED WITHOUT ISSUE. NO OTHER FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE ALLEGED INFLATION ISSUE AS THE BALLOON WAS INFLATED AND DEFLATED WITH NO ISSUE. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED SHAFT DAMAGE AND BALLOON KINK AS KINKS AND TWISTING WERE NOTED TO THE CATHETER, AND A KINK WAS NOTED AT THE BALLOON'S PROXIMAL END. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED SPLIT TIP AS A SPLIT WAS OBSERVED AT THE BALLOON'S TIP. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED INFLATION ISSUE, IDENTIFIED SHAFT DAMAGE, BALLOON KINK AND SPLIT TIP 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 (EXPIRATION DATE: 10/2025) 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 DEVICE ALLEGEDLY HAD AN INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205615 ATLAS GOLD PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93XG0003 00801741060762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown