BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX MEDICAL

    MDR report key: 4787995 · Received May 18, 2015

    Report

    Report Number
    4787995
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    April 17, 2015
    Report Date
    May 14, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE CAME IN FOR CORONARY BYPASS GRAFTING X4 ON (B)(6) 2015. PT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO ICU. ON (B)(6) 2015 THE PT CODED IN ICU AND A HEMOGLOBIN OF 5 WAS FOUND. THE PT WAS TAKEN BACK TO THE OPERATING ROOM. THE FINDINGS WERE THAT THE PT HAD 2 CLIPS OFF THE VEIN BRANCH OF THE SAPHENOUS VEIN TO THE RIGHT CORONARY ARTERY. THESE WERE CLIPPED AND HEMOSTASIS WAS CONTROLLED. AGAIN THE PT WAS SENT BACK TO ICU AND UPON HIS ARRIVAL TO ICU HIS PRESSURES ROSE TO 210/110 AND HE RAPIDLY EXSANGUINATED OUT OF HIS CHEST TUBE. HE BECAME HEMODYNAMICALLY UNSTABLE AND WAS BROUGHT DOWN EMERGENTLY TO THE OPERATING ROOM. FINDINGS: HE HAD 2 ADDITIONAL VEIN CLIPS COME OFF A DIFFERENT VEIN BRAND WHICH WAS APPROXIMATELY 2 CM PROXIMAL TO THE FIRST SET OF CLIPS. THEY WERE CLEARLY PLACED AT THE FIRST OPERATION. (WE DO NOT HAVE THE LOT NUMBER FOR THIS EXACT PRODUCT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321259 TELEFLEX MEDICAL TITANIUM VEIN CLIPS MCW TELEFLEX MEDICAL MEDIUM TITANIUM CLIP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization