BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR BALKIN GUIDING SHEATH

    MDR report key: 1170776 · Received September 17, 2008

    Report

    Report Number
    1820334-2008-00513
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 2008
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE COMPLAINT DEVICE WAS NOT RETURNED, WE ARE UNABLE TO CONFIRM THE VALIDITY OF THIS REPORT. HOWEVER, WE CAN ADVISE THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS AND OTHER SURFACE IMPERFECTIONS, PRIOR TO FURTHER PROCESSING. IN ADDITION, THE APPROPRIATE DILATOR LENGTH AND A SMOOTH TRANSITION IS VERIFIED. WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    DURING A ENDOVASCULAR INTERVENTION PROCEDURE OF THE SFA TO CORRECT "ANESTIMOASIS" OF LEFT FEMORAL POPLITEAL GRAFT, THE SHEATH SEPARATED, UNCOILED AND HAD TO BE SURGICALLY REMOVED IN THE OPERATING ROOM BY A VASCULAR SURGEON. THIS OCCURRED UPON COMPLETION OF THE PROCEDURE, DURING THE ATTEMPT TO REMOVE THE SHEATH FOR A SHORT DIAGNOSTIC SHEATH. ADDITIONAL INFO WAS PROVIDED THAT THE GROIN AREA WAS SEVERELY SCARRED; SO MUCH THAT THE PHYSICIAN WAS UNABLE TO ENITRELY ADVANCE THE SHEATH. A DECISION WAS MADE TO STOP THE PROCEDURE, HOWEVER, UPON THE ATTEMPTED REMOVAL IS WHEN THE SHEATH SEPARATED. A VERY SMALL INCISION WAS MADE IN ORDER TO PLACE A LARGER SHEATH. THE PHYSICIAN WAS ABLE TO CLAMP THE DILATOR TO THE SHEATH AND SUCCESSFULLY REMOVE THE DEVICE. THE PT REQUIRED ONLY A FEW STITCHES AND ONE DAY WAS ADDED TO THE HOSP STAY. MEDWATCH REPORT RECEIVED ON 9/4/2008: BALKIN SHEATH IN LEFT FEMORAL ARTERY AT PROXIMAL ANASTOMOSIS OF FEM-POP GRAFT. BALKIN SHEATH BEING REMOVED WITH ITS ORIGINAL DILATOR AND FRACTURED AT 22CM FROM HUB LEAVING 18CM IN ARTERY. REQUIRED SURGICAL REMOVAL. PT WITH PREVIOUS PERIPHERAL VASCULAR SURGERIES WITH RESULTING SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR BALKIN GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC NA 2008829

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention