BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOFLO VASCULAR GRAFT

    MDR report key: 1045826 · Received May 16, 2008

    Report

    Report Number
    2020394-2008-00133
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 16, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    PMA / PMN Number
    K004012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT/SERIAL NUMBER WAS UNK. THE SAMPLE WAS DISCARDED BY THE FACILITY. BASED ON THE INFO RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNK. THE CURRENT IFU STATES: EXPOSURE TO SOLUTIONS (E.G., ALCOHOL,OIL, AQUEOUS SOLUTIONS, ETC.) MAY RESULT IN LOSS OF THE GRAFT'S HYDROPHOBIC PROPERTIES. LOSS OF THE HYDROPHOBIC BARRIER MAY RESULT IN GRAFT WALL LEAKAGE. PRECLOTTING OF THIS GRAFT IS UNNECESSARY. ADVERSE REACTIONS: POTENTIAL COMPLICATIONS WHICH MAY OCCUR WITH ANY SURGICAL PROCEDURE INVOLVING A VASCULAR PROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO: DISRUPTION OR TEARING OF THE SUTURE LINE, GRAFT, AND/OR HOST VESSEL; SUTURE HOLE BLEEDING; GRAFT REDUNDANCY; THROMBOSIS, EMBOLIC EVENTS, OCCLUSION OR STENOSIS; ULTRAFILTRATION; SEROMA FORMATION; SWELLING OF THE IMPLANTED LIMB; FORMATION OF HEMATOMA OR PSEUDOANEURYSM; INFECTION; ANEURYSM/DILATION; BLOOD LEAKAGE; HEMORRHAGE; STEAL SYNDROME; AND/OR SKIN EROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR GRAFT WAS FOUND TO BE WEEPING AND HAD A GOLF BALL SIZE SEROMA, APPROX 1 WEEK AFTER THE GRAFT WAS IMPLANTED. A TUNNELER WAS USED FOR THE PROCEDURE, BUT IT IS NOT KNOWN WHAT SIZE TIP WAS USED. IT WAS A FISTULA GRAFT IN THE UPPER ARM. IT WAS REPORTED THAT THE DOCTOR DID NOT USE CLAMPS ON THE GRAFT WHEN IMPLANTING, AND THE GRAFT DID NOT COME IN CONTACT WITH ANY ALCOHOL OR BETADINE AND WAS NOT FLUSHED PRIOR TO USE. AFTER SUTURING IN PLACE, THE VENOUS SIDE WAS RELEASED FIRST, THEN THE ARTERIAL SIDE. ONCE THE SEROMA WAS NOTED A WEEK AFTER IT WAS IMPLANTED, THE PT HAD TO GO BACK FOR A REPLACEMENT. A DIFFERENT GRAFT WAS IMPLANTED AND THE PT IS DOING FINE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOFLO VASCULAR GRAFT DYF BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention