BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRANT INTRODUCER SHEATH

    MDR report key: 3840830 · Received May 30, 2014

    Report

    Report Number
    2953200-2014-01081
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K123990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SENTRANT SHEATH WAS USED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 46.1MM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE DIAMETER OF THE PROXIMAL NECK IS 21.1MM AND 23.2MM AT THE DISTAL END. THE PROXIMAL NECK LENGTH IS 10MM. THE INFRARENAL NECK ANGLE IS 42.5 DEGREES. THE ACCESS DIAMETER AT THE RIGHT FEMORAL IS 7.1MM. THE ACCESS DIAMETER AT THE LEFT FEMORAL IS 6.2MM IT WAS REPORTED THAT DURING THE INDEX PROCEDURE EXCESSIVE CALCIUM DEPOSITS RESTRICTED ACCESS. THE PHYSICIAN DILATED THE RIGHT FEMORAL ARTERY WITH ANOTHER MANUFACTURER¿S DEVICE AND A BALLOON ANGIOPLASTY WAS ALSO USED TO IMPROVE PASSAGE. THE PHYSICIAN NOTED THAT THE ACCESS SITE WAS TOO SMALL AND DECIDED TO ABORT THE PROCEDURE, REMOVE THE SHEATH AND CLOSE THE ACCESS SITE. POST OP DAY ONE IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE COLD FEET. THE CAUSE OF THE COLD FEET IS UNKNOWN; HOWEVER, THE PHYSICIAN NOTED THAT IT WAS POSSIBLE THAT THE SHEATHS WERE OCCLUSIVE TO DOWN STREAM FLOW FOR A COUPLE OF HOURS AND OR SHOWERING OF HARD/SOFT PLAQUE UPON REMOVAL OF THE SHEATHS. THE PHYSICIAN DECIDED TO TREAT THE PATIENT BY PERFORMING A BILATERAL FEMORAL ENDART¿S AND A DISTAL PERIPHERAL INTERVENTION PROCEDURE. THE INTERVENTION WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. A REVIEW OF RETURNED PRE-IMPLANT FILMS CONFIRMED THAT THE ACCESS VESSELS WERE SMALL IN CALIBER AND VERY CALCIFIED. IMAGES DURING IMPLANT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318031 SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER DYB MEDTRONIC IRELAND 00091081

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention