BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XXL ESOPHAGEAL

    MDR report key: 8374824 · Received February 27, 2019

    Report

    Report Number
    2134265-2019-01716
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    UDI-DI
    08714729163060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FACILITY MEDWATCH# 5083099 THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 16MM X 4CM, 75 CM XXL ESOPHAGEAL BALLOON CATHETER USED FOR DILATATION. HOWEVER, UPON REMOVING THE INFLATED BALLOON, THE BALLOON SHEARED OFF IN THE LEFT ILIAC VEIN. THE PHYSICIAN ATTEMPTED TO USE A SNARING DEVICE TO RETRIEVE THE DETACHED BALLOON BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN ENDED AND THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU). LATER THAT NIGHT, THE PATIENT WAS AGAIN TRANSFERRED TO CARDIAC CATH LAB WHERE THE PHYSICIAN RE-ATTEMPTED TO SNARE THE BALLOON MATERIAL BUT STILL UNSUCCESSFUL. FINALLY, THE PHYSICIAN DECIDED TO PLACE A SELF-EXPANDING STENT, SUCCESSFULLY TRAPPING THE BALLOON MATERIAL AGAINST THE VESSEL WALL. THE PATIENT WAS THEN TRANSFERRED BACK TO ICU. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169018 XXL ESOPHAGEAL DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION 23375 0022850958 08714729163060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention