BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD FINESSE PATCH

    MDR report key: 1909875 · Received November 24, 2010

    Report

    Report Number
    2242352-2010-03433
    Event Type
    Death
    Date Received
    November 24, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DSY
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEING INVESTIGATED. A LETTER HAS BEEN SENT TO THE HOSPITAL IN AN EFFORT TO OBTAIN ANY ADDITIONAL INFO THAT MAY BE AVAILABLE TO US. THE PT EXPIRED 10 DAYS POST SURGERY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A FINESSE PATCH FOR AN ENDARTERECTOMY CLOSURE THAT WAS NECESSARY PROXIMALLY FROM THE DISTAL ANASTOMOSIS AFTER A FEMORAL-POPLITEAL BYPASS WITH A VEIN GRAFT. THE PT SUFFERED AN INFECTION AFTER HE WAS DISCHARGED FROM THE HOSPITAL. A WOUND VAC (VACUUM ASSISTED CLOSURE) SYSTEM WAS USED TO TREAT THE INFECTION LOCALLY. THE VAC TREATMENT WAS CHANGED DAILY BY A NURSE AT HOME. THE PT EXPIRED 10 DAYS POST SURGERY. AN AUTOPSY WAS PERFORMED ON THE PT, AT WHICH TIME THE PHYSICIAN REPORTED THAT HE EXAMINED THE PATCH AND FOUND THAT THE ANASTOMOSIS WAS INTACT, HOWEVER, A TRANSVERSE CUT OF HALF A CENTIMETER WAS PRESENT ON THE PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD FINESSE PATCH CARDIOVASCULAR FABRIC DSY MAQUET CARDIOVASCULAR, LLC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death