BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER GUIDING SHEATH

    MDR report key: 2002450 · Received February 16, 2011

    Report

    Report Number
    1820334-2011-00101
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    November 25, 2010
    Report Date
    January 28, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNK AS NOT PROVIDED BY REPORTER. SHEATH SEPARATION IS NOT SPECIFICALLY LABELED IN THE IFU BUT BREAKAGE IS. THE DEVICE WAS RETURNED IN A USED AND NONCONFORMING CONDITION: THE EXTENSION TUBE HAD SEPARATED FROM THE SIDE LUMEN OF THE CHECK-FLO BODY WITHOUT EVIDENCE OF ADHESIVE RESIDUE OR MATERIAL TEAR/BREAKAGE. THE CHECK-FLO VALVE ASSEMBLY IS PUT TOGETHER BY CONNECTING TUBE INTO SIDEARM OF SPECIFIED CHECK-FLO BODY. ROTATE TUBING WHILE INSERTING TO ACHIEVE PROPER GLUE COVERAGE BETWEEN THE PARTS, IF REQUIRED. IN-PROCESS INSPECTION FOR LARGE CHECK-FLO VALVE ASSEMBLY WITH THREADED NOSE SECTION IS INSPECTED BY PERFORMING AN AIR PRESSURE TEST ON 100% OF EACH ORDER REC'D. IN-PROCESS AND FINAL INSPECTION FOR CHECK-FLO INTRODUCER PERFORMS 100% INSPECTION OF STOPCOCK, SHRINK TUBE, AND CONNECTING TUBE SECURE ATTACHMENT. ALTHOUGH MULTIPLE PROCESS CONTROLS ARE IN PLACE, UPON VISUAL EXAMINATION OF THE RETURNED DEVICE, NO ADHESIVE RESIDUE IS EVIDENT AT THE FAILED INTERFACE BETWEEN THE CHECK-FLO BODY AND EXTENSION TUBE. MEASURES WERE TAKEN FOR THIS FAILURE MODE AND PRODUCT FAMILY PRIOR TO RECEIPT OF THIS COMPLAINT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. QUALITY ENGINEERING PERFORMED A RISK ANALYSIS FOR THIS PRODUCT FAMILY AND FAILURE MODE, WHICH CONCLUDED THAT RISK REDUCTION ACTIVITIES WERE RECOMMENDED; THEREFORE, MEASURES WERE THEN INITIATED PRIOR TO THE RECEIPT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    SHEATH WAS USED ON THE PT ON (B)(6) 2010. UNFORTUNATELY AFTER THE SHEATH WAS PLACED IN THE FEMORAL ARTERY, THE SIDE ARM CAME OFF THE SHEATH RESULTING IN MASSIVE BLOOD LOSS AND THE PT REQUIRING A BLOOD TRANSFUSION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO ASSIST IN THIS INVESTIGATION. PT OUTCOME WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2537853

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention