BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH INTRODUCER SHEATH

    MDR report key: 4130419 · Received September 30, 2014

    Report

    Report Number
    2134265-2014-06189
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DYB
    PMA / PMN Number
    K060190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GROIN PSEUDOANEURYSM OCCURRED. THE PHYSICIAN WAS UNABLE TO GET ANY WIRE DOWN A KINKED ANTEGRADE 6FR SHEATH IN THE GROIN OF A PATIENT WHO HAD UNDERGONE AN ATTEMPTED SFA ANGIOPLASTY. THIS RESULTED IN LOSS OF ACCESS WHEN THE PHYSICIAN WAS PLANNING TO USE A CLOSURE DEVICE. THIS REQUIRE THE PHYSICIAN TO PRESS ON THE GROIN TO ACHIEVE HEMOSTASIS. DUE TO THE PATIENTS WEIGHT AND HYPERTENSION, THIS RESULTED IN A HEMATOMA AND SUBSEQUENT GROIN PSEUDOANEURYSM. THE PATIENT EXPERIENCED SIGNIFICANT PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609421 SUPER SHEATH INTRODUCER SHEATH INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - MAPLE GROVE M00115962B1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention