BEUDAMED
    FDA Adverse Event Injury Summary report: N

    360 EXPRESS BALLOON

    MDR report key: 5518127 · Received March 22, 2016

    Report

    Report Number
    3004904811-2016-00023
    Event Type
    Injury
    Date Received
    March 22, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 2, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    GEI
    PMA / PMN Number
    K142364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE#: (B)(4). THE SAMPLE IS NOT AVAILABLE FOR RETURN. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR ABLATION WITH 6CM OF FLAT HGD. AFTER EXAM MUCOMYST WAS APPLIED AND GUIDEWIRE WAS PLACED INTO THE ANTRUM. A 360 EXPRESS WAS PASSED OVER THE GUIDEWIRE FOLLOWED WITH THE SCOPE. PROXIMAL ABLATION WAS PERFORMED AND THE DEVICE WAS ADVANCED 4CM AND A 2ND ABLATION WAS PERFORMED. THE SCOPE, 360 EXPRESS AND GUIDEWIRE WERE REMOVED. A BARRX CLEANING CAP WAS PLACED ON THE DISTAL TIP OF THE SCOPE AND INSERTED INTO THE PATIENT TO REMOVE THE COAGULATED TISSUE. IT WAS THEN NOTICED THAT A 4CM ESOPHAGEAL TEAR OCCURRED IN THE DISTAL ESOPHAGUS. AFTER IT WAS CONFIRMED THAT THERE WAS NO ACTIVE BLEEDING THE DECISION WAS MADE TO ABORT THE PROCEDURE AND 2ND ROUND OF ABLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174431 360 EXPRESS BALLOON ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI MEDTRONIC 64082 F2500165X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other