BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1182395 · Received September 19, 2008

    Report

    Report Number
    3004904811-2008-00013
    Event Type
    Other
    Date Received
    September 19, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH VERY LONG SEGMENT (13CM) DYSPLASTIC BARRETT'S ESOPHAGUS. VERY NARROW UPPER SEGMENT OF ESOPHAGUS CONTAINING DYSPLASTIC TISSUE NOT TREATED AT FIRST RFA SESSION. NO COMPLICATIONS AT FIRST SESSION. TWO MONTHS LATER ((B) (6) 2008), PROXIMAL DISEASED TISSUE (UNTREATED) PERSISTED AS EXPECTED. USING A 28MM CATHETER, PHYSICIAN ATTEMPTED TO TREAT NARROWED AREA, HOLDING CATHETER IN PLACE DURING INFLATION. THEY NOTED A MUCOSAL INJURY IN THAT NARROWED AREA, PLACED ENDOSCOPIC CLIPS, AND ACQUIRED A CT SCAN. NO FLUID EXTRAVASATION, BUT SOME AIR NOTED AT CLIPPING SITE (MICRO-PERFORATION). PATIENT WAS ADMITTED, MADE NPO, GIVEN ANTIBIOTICS, AND A CT REPEATED ON DAY 4, WHICH WAS NORMAL. PATIENT DISCHARGED TO HOME IN STABLE CONDITION ON (B) (6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention