BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEALPTFE

    MDR report key: 1802908 · Received August 10, 2010

    Report

    Report Number
    MW5017078
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    June 3, 2010
    Report Date
    August 10, 2010
    Manufacturer
    VASCUTEK
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS END STAGE RENAL DISEASE AND UNDERWENT CREATION OF AN ARTERIOVENOUS FISTULA WITH NONAUTOGENOUS GRAFT ON (B)(6) 2010. THE GRAFT WAS A VASCUTEK SEALPTFE GRAFT. THE INFLOW TO THE GRAFT WAS FROM THE DISTAL BRACHIAL ARTERY AND THE OUTFLOW WAS THE AXILLARY VEIN. INITIAL ACCESS FLOW WAS 1975ML PER MIN. AT THE FIRST POSTOPERATIVE VISIT ON (B)(6) 2010 THE PT WAS FOUND TO HAVE MILD SWELLING AND MILD BRUISING. THERE WERE NO ISCHEMIC SYMPTOMS. INTRA-ACCESS FLOW WAS 3,100 ML PER MIN -DUPLEX METHODOLOGY-. THE SECOND POSTOP VISIT THE PT COMPLAINED OF MILD LEFT ARM STINGING PAIN BUT DENIED HAND PAIN. THERE WAS PERSISTENT LEFT ARM SWELLING CATEGORIZED AS "MILD TO MODERATE". IT WAS TOO SWOLLEN FOR CANNULATION. INTRA-ACCESS FLOW WAS 1,628 ML/MINUTE -DUPLEX METHODOLOGY- AT THE THIRD POSTOP VISIT ON (B)(6) 2010 THERE WAS A LARGE SEROMA OVER THE MIDDLE AND DISTAL 1/3 OF THE ARM. INTRA ACCESS FLOW WAS 2,023 ML PER MIN. NO CANNULATION WAS ATTEMPTED. ON (B)(6) 2010 SEROMA ASPIRATED: 14 ML YELLOW SERUM. NO BLOOD OR HEMATOMA. ACCESS FLOW 1,441 MO/MINUTE. ON (B)(6) 2010 SEROMA AND SWELLING WORSE. EXPLANTATION OF GRAFT RECOMMENDED AS SOON AS POSSIBLE. PT REQUESTED PROCEDURE BE DEFERRED UNTIL AFTER (B)(6) FOR PERSONAL REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE GELATIN SEALED EPTFE GRAFT DSY VASCUTEK P2538/3B 2031

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability