BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOFLO VASCULAR GRAFTS

    MDR report key: 6173561 · Received December 14, 2016

    Report

    Report Number
    2020394-2016-01173
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    UDI-DI
    00801741021558
    PMA / PMN Number
    K004012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL INSPECTION: A SEGMENT OF THE GRAFT WAS RETURNED WITH THE PRODUCT PACKAGING AND LABEL. THE GRAFT SEGMENT HAD TWO BLUE LINES RUNNING LONGITUDINALLY AND HAD CARBON LINING, WHICH IDENTIFIED THE PRODUCT AS A BARD GRAFT. THE SEGMENT MEASURED 4.1CM IN LENGTH AT ITS LONGEST POINT. THE BEADING WAS MISSING ALONG ENTIRE RETURNED LENGTH. IT APPEARED THAT ONE END OF THE RETURNED GRAFT WAS CUT. THE OTHER END APPEARED TO BE TORN. THERE WAS A TEAR ALONG THE BEADING TRACK OF THE RETURNED SEGMENT. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED FOR REVIEW. CONCLUSION: THE INVESTIGATION WAS CONFIRMED FOR TORN MATERIAL, AS THE RETURNED SEGMENT HAD A TEAR ALONG THE BEADING TRACK. IT WAS UNKNOWN IF PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE WAS UNKNOWN. LABELING REVIEW: THE CURRENT IFU STATES: PRECAUTIONS: WHEN REMOVING THE EXTERNAL SPIRAL SUPPORT (BEADING) OF THE GRAFT, THE BEADING MUST BE REMOVED SLOWLY AND AT A 90° ANGLE TO THE GRAFT. RAPID UNWINDING AND /OR REMOVAL AT LESS THAN A 90° ANGLE MAY RESULT IN GRAFT DAMAGE. DO NOT USE SURGICAL BLADES OR SHARP, POINTED INSTRUMENTS TO REMOVE THE BEADING AS THIS MAY DAMAGE THE GRAFT WALL. IF DAMAGE OCCURS, THAT SEGMENT OF THE GRAFT SHOULD NOT BE USED. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 1

    NO DEVICE, NO MEDICAL RECORDS, OR NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, AN ALLEGED TEAR IN THE VASCULAR GRAFT WAS IDENTIFIED UPON REMOVAL OF THE BEADING. THE HEALTH CARE PROVIDER REMOVED THE TORN SEGMENT AND COMPLETED THE PROCEDURE WITH THE VASCULAR GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, AN ALLEGED TEAR IN THE VASCULAR GRAFT WAS IDENTIFIED UPON REMOVAL OF THE BEADING. THE HEALTH CARE PROVIDER REMOVED THE TORN SEGMENT AND COMPLETED THE PROCEDURE WITH THE VASCULAR GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824930 CARBOFLO VASCULAR GRAFTS EPTFE VASCULAR GRAFT DYF BARD PERIPHERAL VASCULAR, INC. VTZL0360 00801741021558

    Patients

    Seq Age Sex Outcome Treatment
    1