BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 2115253 · Received May 12, 2011

    Report

    Report Number
    1820334-2011-00241
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 15, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED BUT PHOTOS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. FINAL INSPECTION FOR ANSEL FLEXOR TUOHY BORST INTRODUCER WITH HYDROPHILIC COATING, CONFIRMS CORRECT FITTINGS AND THE FITTINGS ARE SECURE AND THAT THE STOPCOCK IS FREE OF CRACKS AND OVERALL APPEARANCE MUST BE CLEAN. THE FITTINGS ARE ALSO VERIFIED FOR SECURITY. EACH FLARE IS CHECKED WITH APPROPRIATE FLARE GAUGE. FURTHERMORE, INSTRUCTIONS FOR USE (IFU) INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH AND WARNS, "BEFORE WITHDRAWING THE SHEATH THROUGH TORTUOUS ANATOMY, INSERT THE INTRODUCER DILATOR TO AVOID POSSIBLE BREAKAGE." PROVIDED PHOTOS SHOW THE CHECK-FLO VALVE HAD SEPARATED FROM THE SHEATH. WHILE THIS COMPLAINT IS RELEVANT TO THE SCOPE OF CAPA FOR PROXIMAL FITTING SEPARATION FROM SHEATHS, THIS CAPA WAS ISSUED AT MANAGEMENT DISCRETION PRIOR TO THE RECEIPT OF THIS COMPLAINT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. RELEVANT TO THIS FAILURE MODE OF HUB SEPARATION, THIS DEVICE WAS MANUFACTURED AFTER THE IMPLEMENTATION OF CAPA VIA A CHANGE REQUEST ON 6/27/2008. IN ADDITION, PREVENTIVE ACTION WAS INITIATED FOR PROXIMAL FITTING SEPARATION FROM SHEATHS, AT MANAGEMENT DISCRETION PRIOR TO THE RECEIPT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    UPON COMPLETION OF THE PROCEDURE THE ANSEL WAS BEING REMOVED TO EXCHANGE FOR A SHORT 6FR SHEATH; HOWEVER, THE HUB PULLED OFF THE ANSEL SHEATH. THE SHEATH WAS CLAMPED, AND THE ANSEL WAS REMOVED OVER THE WIRE THAT WAS IN PLACE WITHOUT ANY INCIDENT. THE SHORT 6FR SHEATH WAS PLACED, NO HARM TO THE PT. THE FOLLOWING ADDITIONAL INFORMATION WAS REC'D VIA MEDWATCH REPORTED ON 4/21/2011: DURING THE PROCEDURE, WHILE EXCHANGING THE 55CM SHEATH, THE HUB BECAME DISCONNECTED FROM THE BODY OF THE SHEATH. THE PROCEDURE WAS AN ABDOMINAL AORTOGRAM WITH SELECTIVE LEFT LOWER EXTREMITY ANGIOGRAPHY AS WELL AS SELECTIVE RIGHT LOWER EXTREMITY ANGIOGRAPHY WITH RUNOFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2579505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR