BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8930840 · Received August 26, 2019

    Report

    Report Number
    3007284313-2019-00261
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    July 30, 2019
    Report Date
    October 24, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITION G5: 510(K) NUMBER: K172567.

    Additional Manufacturer Narrative · 0

    CORRECTION B5.

    Description of Event or Problem · 0

    ON (B)(6), 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS.

    Additional Manufacturer Narrative · 1

    THE UDI FOR THE MOB37 BALLOON IS NOT AVAILABLE SINCE THE DEVICE LOT NUMBER IS UNAVAILABLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE WAS NOT POSSIBLE SINCE THE DEVICE LOT NUMBER IS UNAVAILABLE. PER THE GORE® MOLDING AND OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE VESSEL WALL, INCLUDING DISSECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE ENDOPROSTHESIS WAS DEPLOYED, AND TOUCH-UP BALLOONING WAS PERFORMED USING A GORE® MOLDING AND OCCLUSION BALLOON CATHETER. POST IMPLANT AND BALLOONING, A LOCALIZED DISSECTION AT THE DISTAL EDGE OF THE CONTRALATERAL LEG COMPONENT IN THE RIGHT COMMON ILIAC ARTERY WAS OBSERVED, AND THE PHYSICIAN ELECTED TO MONITOR IT. NO FURTHER ISSUE REPORTED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726609 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization