BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 19927346 · Received August 7, 2024

    Report

    Report Number
    2020394-2024-01179
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    June 27, 2024
    Report Date
    May 8, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741023514
    PMA / PMN Number
    K983861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D2B (DYF;DSY), D4 (EXPIRY DATE: 10/2028). 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.

    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 DISTAFLO GRAFT RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, THE SAMPLE WAS NOTED TO HAVE RESIDUE THROUGHOUT. THE GRAFT MEASURED APPROXIMATELY 50.7CM FROM END TO END. THE GRAFT WAS CUT IN END ONE. BEADING DETACHMENT WAS NOTED FROM 29.4CM UNTIL 33.5CM. INDENTATIONS WERE NOTED THROUGHOUT THE DETACHED PORTION OF THE GRAFT. BEADING MARKS WERE NOTED THROUGHOUT THE CENTER OF THE GRAFT. NO FUNCTIONAL EVALUATION WAS PERFORMED DUE TO THE NATURE OF THE EVENT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BEADING PEELED ISSUE AS BEADING DETACHMENT WAS NOTED ON THE GRAFT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED BEADING PEELED ISSUE 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: G3, H6 (METHOD). H11: D2B (DYF, DSY), D4 (UNIQUE IDENTIFIER (UDI) #), 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANTATION PROCEDURE, THE GRAFT ALLEGEDLY FELL APART WHILE TRYING TO INSERT INTO THE BODY. IT WAS FURTHER REPORTED THAT RINGS ON THE OUTSIDE OF THE GRAFT STARTED UNCOILING OFF THE GRAFT, THEREFORE THE MIDDLE PIECE OF THE GRAFT WAS EASILY ABLE TO COLLAPSE. THE PROCEDURE WAS COMPLETE USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANTATION PROCEDURE, THE GRAFT ALLEGEDLY FELL APART WHILE TRYING TO INSERT INTO THE BODY. IT WAS FURTHER REPORTED THAT RINGS ON THE OUTSIDE OF THE GRAFT STARTED UNCOILING OFF THE GRAFT, THEREFORE THE MIDDLE PIECE OF THE GRAFT WAS EASILY ABLE TO COLLAPSE. THE PROCEDURE WAS COMPLETE USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565839 DISTAFLO BYPASS GRAFT EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTHX0366 00801741023514

    Patients

    Seq Age Sex Outcome Treatment
    1