BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEXOR CHECK-FLO INTRODUCER

    MDR report key: 1091724 · Received July 23, 2008

    Report

    Report Number
    1820334-2008-00365
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 23, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED TO ASSIST WITH OUR INVESTIGATION; THEREFORE, WE WERE NOT ABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THIS EVENT. HOWEVER, A CORRECTIVE ACTION WAS PREVIOUSLY INITIATED IN AN EFFORT TO MINIMIZE FUTURE OCCURRENCES. THIS PROD GROUP IS INSPECTED 100% FOR BENDS, KINKS, PROPER SECUREMENT OF PROXIMAL FITTINGS AND OTHER SURFACE IMPERFECTIONS PRIOR TO SHIPPING. THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS EVENT AND WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    IN 2008, THE CARDIAC CATH LAB HAD A CASE ON A MALE PT. THE PT WAS TO RECEIVE AN ATHERECTOMY OF THE LOWER EXTREMITY. UPON PLACING THE 7.0 FR SHEATH, THE DISTAL TIP WAS ELONGATED. DIFFICULTY HAD BEEN ENCOUNTERED ADVANCING AND REMOVING THE SHEATH FROM THE PT. WHILE THE PHYSICIAN ATTEMPTED TO REMOVE THIS SHEATH, HE HAD DIFFICULTY ATTEMPTING TO REMOVE IT FROM THE PT WHILE MAINTAINING WIRE PLACEMENT. A SIGNIFICANT AMOUNT OF BLOOD WAS LOST WHILE TRYING TO REPLACE THIS SHEATH. THE SHEATH WAS WITHDRAWN AND REPLACED WITH ANOTHER SHEATH OF THE SAME TYPE. UPON INTRODUCTION OF THE POLAR CATH BALLOON, THE HEMOSTATIC VALVE POPPED OFF THE SHEATH. THE PT SUSTAINED SIGNIFICANT BLOOD LOSS. AS A RESULT, THE OUT-PATIENT PROCEDURE TURNED INTO AN OVERNIGHT ADMISSION TO THE ICU. PT IS OKAY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEXOR CHECK-FLO INTRODUCER DYB INTRODUCER CATHETER DYB COOK, INC. NA 2079002

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R