BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 2973976 · Received February 13, 2013

    Report

    Report Number
    1820334-2013-00070
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLOOD TRANSFUSION IS NOT ADDRESSED IN THE IFU. LEAKS IS NOT ADDRESSED IN THE IFU. THE DEVICE WAS RETURNED IN A USED, BUT OTHERWISE UNREMARKABLE, CONDITION. PER SPECIFICATION, QUALITY CONTROL PERSONNEL PERFORMS AN AIR PRESSURE TEST ON 100% OF EACH ORDER RECEIVED. DEVICES ARE INSPECTED 100% FOR LEAKAGE AND FUNCTIONAL TESTING COULD NOT CONFIRM THE FAILURE MODE OF LEAKAGE; THEREFORE, THE DEVICE PERFORMED AS INTENDED. THE DEVICES ARE ALSO 100% INSPECTED IN PROCESS FOR LEAKAGE PRIOR TO SHIPPING. DURING INVESTIGATION, THE DEVICE WAS FLUSHED VIA THE SIDEARM WITHOUT LEAKAGE IN BOTH AN OPEN LUMEN AND AN OBSTRUCTED LUMEN CONDITION. THE LUER LOCK OF THE STOPCOCK IS SECURELY THREADED ONTO THE LUER LOCK ADAPTER; HOWEVER, IT IS NOT AFFIXED WITH ADHESIVE. WHILE IT IS FEASIBLE THAT THE LUER LOCK MAY HAVE LOOSENED DURING PREPARATION FOR THE PROCEDURE, ANY SUBSEQUENT LEAKAGE COULD BE PREVENTED BY RETHREADING IT ONTO THE ADAPTER. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. THE PATIENT RISK FOR THIS FAILURE MODE AND PRODUCT FAMILY HAD BEEN ADDRESSED BY A RISK SPECIFICATION, WHICH INDICATES INSUFFICIENT RISK EXISTS TO WARRANT FURTHER ACTIVITIES DUE IN PART TO LOW OCCURRENCE AND LOW SEVERITY.

    Description of Event or Problem · 1

    DURING STENT GRAFT PLACEMENT FOR AAA REPAIR, A COOK PERFORMER INTRODUCER ((B)(4)) WAS INSERTED. AFTER A WHILE, BLOOD LEAKAGE WAS DETECTED AT THE SIDEARM AND STOPCOCK CONNECTION PART. UPON COMPLETION OF THE PROCEDURE, THE SHEATH WAS REPLACED AND A BLOOD TRANSFUSION WAS PERFORMED. BLOOD TRANSFUSION VOLUME IS UNDER INVESTIGATION. HEMORRHAGE VOLUME WAS 1000CC AND THE PATIENT IS GOING TO BE DISCHARGED SOMETIME THIS WEEK. PATIENT IS NOT IN A SEVERE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64333 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK, INC. NA F3587839

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention