BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGAGE INTRODUCER, TF 6 FR 12 CM 0.038 GW

    MDR report key: 1884068 · Received October 20, 2010

    Report

    Report Number
    2182269-2010-00188
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K092575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ENGAGE HEMOSTASIS INTRODUCER SHEATH INSTRUCTION FOR USE (IFU) STATES INSERTION INTO ARTERY MAY CAUSE EXCESSIVE BLEEDING, VASOSPASM, VESSEL TRAUMA, AND/OR OTHER COMPLICATIONS. THE ENGAGE HEMOSTASIS INTRODUCER SHEATH INSTRUCTION FOR USE (IFU) STATES UPON REMOVAL OF HEMOSTASIS INTRODUCER, PROPER PRECAUTIONS SHOULD BE TAKEN TO PREVENT BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH CALCIFIED PLAQUE IN THE COMMON ARTERY HAD A CATHETERIZATION PROCEDURE AND A COMPETITOR SHEATH WAS USED. PRIOR TO BEING SENT TO RECOVERY, THE COMPETITOR SHEATH WAS EXCHANGED FOR AN ENGAGE INTRODUCER SHEATH. WHEN THE HOSPITAL STAFF WAS INSTRUCTED TO REMOVE THE SHEATH, IT WAS REMOVED WITH DIFFICULTY AND THE SHEATH WAS DAMAGED DURING THE REMOVAL PROCESS. A HEMATOMA HAD FORMED AT THE ACCESS SITE AND A 2 CM PORTION OF THE SHEATH WAS LEFT BEHIND IN THE PT, WHICH HAD TO BE SURGICALLY REMOVED. THE PT RECOVERED WITH NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGAGE INTRODUCER, TF 6 FR 12 CM 0.038 GW INTRODUCER DEVICE DYB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R