BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL VENOUS DRAINAGE CANNULA

    MDR report key: 71462 · Received February 27, 1997

    Report

    Report Number
    55108-1997-00004
    Event Type
    Injury
    Date Received
    February 27, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 24, 1997
    Manufacturer
    DLP, INC.
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A SUCCESSFUL CORONARY ARTERY BYPASS GRAFT VIA MINIMALLY INVASIVE APPROACH. THE ENDOCORONARY SINUS CATHETER (ESC), ENDOPULMONARY VENT (EPV) AND ENDOVENOUS DRAINAGE CANNULA (EVDC) WERE PLACED ACCORDING TO THE INSTRUCTIONS FOR USE. UPON PERFORMING THE PERICARDIOTOMY, THE SURGEON NOTED A HEMATOMA IN THE RIGHT VENTRICULAR WALL AND A 1 CM PERFORATION. THIS REQUIRED 1 SUTURE. THE MECHANISM OF THE PERFORATION WAS NOT DEFINED. THE PLACEMENT OF THE ESC AND EPV WERE DESCRIBED BY THE ANESTHESIOLOGIST AS UNEVENTFUL. DURING PLACEMENT OF THE DEVICE, THE GUIDEWIRE WAS SEEN TO ENTER THE RIGHT VENTRICLE A FEW TIMES (AS OPPOSED TO REMAINING WITHIN THE ATRIUM AND VENA CAVAE AS INTENDED), BUT PLACEMENT WAS OTHERWISE UNEVENTFUL. THE ATTENDING SURGEON STATED THAT THE EVENT WAS OF NO CLINICAL CONSEQUENCE, AND THAT IT WAS UNEVENTFUL IN THE COURSE OF A CARDIAC OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL VENOUS DRAINAGE CANNULA CANNULA DWF DLP, INC. EVDC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention