BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA

    MDR report key: 17681039 · Received September 5, 2023

    Report

    Report Number
    2020394-2023-00645
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 8, 2023
    Report Date
    November 16, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    UDI-DI
    00801741090875
    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 PTV DILATION CATHETER WAS RETURNED FOR EVALUATION. NO SPECIFIC ANOMALIES WERE NOTED DURING THE VISUAL EVALUATION. ON FUNCTIONAL TESTING, THE RETURNED CATHETER WAS INFLATED WITH AN IN-HOUSE PRESTO INFLATION DEVICE AND WATER WAS LEAKING FROM THE PIN-HOLE BALLOON RUPTURE. NO OTHER FUNCTIONAL TESTING WAS PERFORMED. AS A PINHOLE RUPTURE WAS NOTED ON THE RETURNED DEVICE DURING THE MICROSCOPIC OBSERVATION, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BALLOON RUPTURE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE 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: 06/2026), 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.

    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 (EXPIRY DATE: 06/2026). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : DEVICE PENDING RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA THE ILIAC VEIN ACCESS, THE BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE AT 16 ATM POST DILATING A STENT ON THE THIRD INFLATION ATTEMPT. 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 BALLOON ALLEGEDLY BURST WHEN INFLATED AT 16 ATM POST DILATING A STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560681 VIDA BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93TH0043 00801741090875
    1599532 VIDA BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93TH0043 00801741090875

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male