BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 1934164 · Received December 16, 2010

    Report

    Report Number
    3004904811-2010-00074
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    August 6, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BARRX MEDICAL, INC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT OCCURRING IN THE (B)(6) REGISTRY. THE PT HAD A VERY LONG 19-CM BARRETT'S ESOPHAGUS WITH INVASIVE ESOPHAGEAL ADENOCARCINOMA. THE PT'S BARRETT'S HISTORY WAS COMPLEX, WITH PREVIOUS ARGON PLASMA COAGULATION AND ENDOSCOPIC MUCOSAL RESECTION (RESULTS NOT AVAILABLE). ABLATIVE THERAPY WITH RFA WAS SELECTED AS NEXT THERAPY. THE PT WAS TAKING ASPIRIN AND CLOPIDOGREL FOR RECENT CORONARY STENT PLACEMENT (SEE WARNINGS AND PRECAUTIONS REGARDING ANTI-PLATELET AGENTS AS SIGNIFICANT RISK FACTOR FOR POST-RFA BLEEDING IN PRODUCT LABELING). TWO DAYS AFTER A CIRCUMFERENTIAL ABLATION, THE PT WAS SEEN AT THE HOSP WITH SYMPTOMS SUGGESTIVE OF A GI BLEED. ENDOSCOPY SHOWED THAT THERE WAS A LIKELY SITE OF PREVIOUS BLEEDING IN THE DISTAL ESOPHAGUS WITHIN THE ABLATION ZONE. AS THERE WAS NO ACTIVE BLEEDING, THE PT WAS TREATED CONSERVATIVELY WITH IV PPI AND STOPPAGE OF ANTI-PLATELET AGENTS. ADVERSE EVENT IS RESOLVED. THE PT WAS NOT GIVEN A BLOOD TRANSFUSION. PER THE CASE REPORT FORM, THE EVENT SEVERITY WAS NOTED AS SERIOUS, RELATIONSHIP TO DEVICE PROCEDURE WAS PROBABLE, AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INC 90-9100 F1013166

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization