BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    360 EXPRESS BALLOON

    MDR report key: 6141298 · Received December 2, 2016

    Report

    Report Number
    3004904811-2016-00109
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 16, 2016
    Manufacturer
    SUNNYVALE
    Product Code
    GEI
    PMA / PMN Number
    K142364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PATIENT WITH NO SIGNIFICANT PMH PRESENTED WITH C4M5 BE WITH LGD (AFTER PRIOR ER FOR FOCAL VISUAL ABNORMALITY CONTAINING LGD). UPON INITIAL ENDOSCOPY, NO OTHER UNUSUAL FINDINGS WERE NOTED. DIRECTLY AFTER THE FIRST ABLATION PASS WITH THE DEVICE, A MODERATE MUCOSAL LACERATION? WAS NOTICED WITHIN THE ABLATION ZONE. IT IS UNCLEAR IF THE CATHETER WAS UNDER DIRECT VISUALIZATION WHEN THE INJURY OCCURRED BUT NO CATHETER ABNORMALITIES WERE REPORTED. THEREFORE, THE SECOND ABLATION PASS WAS AVOIDED. NO PERFORATION WAS NOTED. MINOR BLEEDING OCCURRED BUT STOPPED SPONTANEOUSLY WITHIN 5 MINUTES. NO INTERVENTION WAS NEEDED. THE NEXT ENDOSCOPY IS SCHEDULED FOR (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792459 360 EXPRESS BALLOON ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SUNNYVALE 64082 F25000166X

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR