BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR SHUTTLE GUIDING SHEATH

    MDR report key: 1545980 · Received November 13, 2009

    Report

    Report Number
    1820334-2009-00640
    Event Type
    Injury
    Date Received
    November 13, 2009
    Date of Event
    August 11, 2009
    Report Date
    October 19, 2009
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION; HOWEVER, WE CAN ADVISE THAT THE INTEGRITY OF THIS DEVICE IS VERIFIED PRIOR TO FURTHER PROCESSING. PER A CHANGE REQUEST IMPLEMENTED ON 06/27/08, A NEW TOOL AND EQUIPMENT IS USED FOR TIGHTENING OF CHECK-FLO AND ADAPTER TO CAP. WHILE THIS CHANGE IS INTENDED TO REDUCE THE OCCURRENCE OF THE MATERIAL SEPARATING FROM THE PROXIMAL FITTING, WE ARE AWARE OF THE POTENTIAL POSSIBILITY AND WILL CONTINUE TO CHECK FOR THESE COMPLAINTS. WE ARE CONTINUING OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT.

    Description of Event or Problem · 1

    INFO PROVIDED TO COOK INC VIA FDA MEDWATCH PROGRAM # (B) (4): THE SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY. THE SHEATH WAS EXCHANGED FOR AN 8FR LONG SHEATH, 90CM. A LONG WOOLEY WIRE WAS ADVANCED ACROSS THE LESION, AFTER WHICH DIRECT STENTING COULD NOT BE DONE DUE TO THE SEVERITY OF THE STENOSES, WHICH WAS IN THE RANGE OF ABOUT 90%. BALLOON ANGIOPLASTY WAS DONE WITH A 6MM WIRE 20MM BALLOON. AT THAT TIME, IT WAS REALIZED THAT THE SHEATH BROKE AT THE HUB AND THE PT WAS HAVING QUITE A BIT OF BLEEDING. THE BALLOON WAS REMOVED AND THE SHEATH WAS CHANGED. AT THAT TIME, THE PT HAD A SIGNIFICANT BRADYCARDIC EPISODE, CONSISTENT WITH VASOVAGAL RESPONSE WITH COMPLETE HEART BLOCK. SHE RESPONDED TO 2MG OF ATROPINE. BY THAT TIME, THE SHEATH WAS CHANGED TO AN INTACT 8FR 90CM SHEATH. SIGNIFICANT LOCALIZED DISSECTION WAS NOTED AFTER THE BALLOON. SUCCESSFUL ANGIOPLASTY AND STENTING WAS DONE WITH THE GENESIS 8MM X 27MM STENT, WHICH GAVE 0% STENOSES. EXCELLENT FLOW WAS NOTED. PT WAS BROUGHT TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR SHUTTLE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2295694

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention