BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTCA

    MDR report key: 2115376 · Received May 23, 2011

    Report

    Report Number
    2115376
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 5-FRENCH SHEATH CATHETER WAS PLACED INTO THE SAPHENOUS VEIN. THIS WAS IN PREPARATION FOR GROIN CANNULATION WITH A 17-FRENCH VENOUS CANNULA. SUBSEQUENTLY, THE PATIENT WAS HEPARINIZED AND THE ASCENDING AORTA WAS CANNULATED FOR PERFUSION. A SINGLE ATRIAL CANNULA WAS INSERTED THROUGH THE RIGHT ATRIAL APPENDAGE AND HYPOTHERMIC CARDIOPULMONARY BYPASS WAS COMMENCED WITH A FLOW OF 80 ML/KG/MINUTE. THE PATIENT WAS GRADUALLY COOLED TO NASOPHARYNGEAL TEMPERATURES OF 28. THE GROIN WAS THEN INSPECTED, AND UPON INSPECTION OF THE GROIN, WE FOUND THAT THE CATHETER THAT WAS PLACED AT THE GROIN CANNULA HAD BROKEN AT THE HUB, AND THE HUB REMAINED OUTSIDE WHEREAS THE CATHETER WAS INSIDE THE PATIENT. THE SUPERIOR VENA CAVA WAS THEN INSPECTED AND HER CATHETER WAS AROUND HER CANNULA WITHIN THE SUPERIOR VENA CAVA. THE CATHETER WAS THEN REMOVED COMPLETELY FROM THE SUPERIOR VENA CAVA AND WAS MAINTAINED AS A SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA PERCUTANOUS INTRODUCER KIT DQO ORIGEN BIOMEDICAL, INC. * G14562

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR