BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRA VASCULAR GRAFT

    MDR report key: 16527206 · Received March 12, 2023

    Report

    Report Number
    2020394-2023-00166
    Event Type
    Malfunction
    Date Received
    March 12, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741022159
    PMA / PMN Number
    K004011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 IMPRA VASCULAR GRAFT WAS RETURNED FOR EVALUATION. UPON FUNCTIONAL TEST AND MICROSCOPIC EVALUATION, WATER WAS NOTED TO BE LEAKING THROUGHOUT THE GRAFT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE LEAK ISSUE AS THERE IS LEAK OBSERVED IN THE GRAFT. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED LEAK ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRATION DATE: 08/2027), G3, H6 (METHOD). H11: H6 (RESULT, CONCLUSION). 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 : SEE H10.

    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 DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRATION DATE: 08/2027).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE GRAFT PLACEMENT PROCEDURE IN AN UPPER ARM ARTERIAL VASCULAR FISTULA, THE DEVICE WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE GRAFT PLACEMENT PROCEDURE IN AN UPPER ARM ARTERIAL VASCULAR FISTULA, THE DEVICE WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445647 IMPRA VASCULAR GRAFT EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. CF40A64 VTGV0366 00801741022159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown