BEUDAMED
    FDA Adverse Event Other Summary report: N

    PTFE VASCULAR GRAFTS SOFT (STEP/TAPER)

    MDR report key: 871833 · Received June 25, 2007

    Report

    Report Number
    6000072-2007-00025
    Event Type
    Other
    Date Received
    June 25, 2007
    Date of Event
    June 12, 2007
    Report Date
    June 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PRODUCT IS AVAILABLE TO BE RETURNED FOR OUR EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. FOLLOWING OUR INVESTIGATION, WHICH INCLUDED THE PHYSICIAN'S REPORT IN THIS MEDWATCH REPORT, WE HAVE CONCLUDED THAT DUE TO A LACK OF SUFFICIENT INFORMATION, A PROBABLE ROOT CAUSE FOR THE INITIAL SERUM LEAKAGE PART OF THE INCIDENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, THE PHYSICIAN'S ELECTING TO CLOSE THE PATIENT BEFORE THE SERUM LEAKAGE COULD BE STOPPED IS CONSISTENT WITH A SURGICAL DECISION MADE IN THE OPERATIONAL CONTEXT OF THE PROCEDURE. SHOULD SUCH INFORMATION BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION - THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH. THERE IS NO INCREASE IN THE FREQUENCY OR SEVERITY AS INDICATED VIA AN ANTICIPATED OR KNOWN FAILURE MODE BASED UPON RISK DOCUMENTATION AND/OR HISTORICAL TRENDING.

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED FOR A LOOP GRAFT FISTULA PROCEDURE. AT THE CLOSURE OF THE PROCEDURE, THE PHYSICIAN OBSERVED SOME SEEPAGE OF PLASMA OR CLEAR FLUID (SERUM) THROUGH THE SUTURE HOLES AT THE 4MM END OF THE GRAFT'S ANASTOMOSIS SITE. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THE GRAFT WAS LEFT IN. THERE WERE NO COMPLICATIONS TO THE PATIENT. THE PATIENT'S POST-OPERATIVE CONDITION WAS FINE. ON 17 JUNE 2007, WE RECEIVED THE FOLLOWING INFORMATION DIRECTLY FROM THE PHYSICIAN: "THE SERUM LEAK OCCURRED ADJACENT TO, BUT NOT AT THE ARTERIAL ANASTAMOSIS. IT WAS IN THE FIRST 3 OR 4 CM OF THE 4MM GRAFT. I DID NOT REALLY NOTICE IT UNTIL I'D COMPLETED BOTH ANASTAMOSES AND INITIATED FLOW THROUGH THE GRAFT. I WATCHED IT FOR ABOUT 10 MINUTES AND WOULD ESTIMATE THE VOLUME OF SEEPING TO BE AROUND 100 CC. I CLOSED BEFORE IT STOPPED AND ANTICIPATE A FLUID COLLECTION WILL RESULT, BUT HAVE NOT SEEN THE PATIENT BACK YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTFE VASCULAR GRAFTS SOFT (STEP/TAPER) VASCULAR GRAFT DSY BOSTON SCIENTIFIC WAYNE 489447 9307313

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other