BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1933839 · Received December 16, 2010

    Report

    Report Number
    3004904811-2010-00072
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A (B)(6) FEMALE WITH SEVERE GERD AND BARRETT'S ESOPHAGUS WHO UNDERWENT A CIRCUMFERENTIAL ABLATION PROCEDURE. ENDOSCOPY PRIOR TO ABLATION REVEALED A 2 CM HIATAL HERNIA. THE FIRST PASS WITH ABLATION AND CLEANING OF COAGULUM WAS PERFORMED WITHOUT ISSUE. THE GUIDEWIRE WAS PLACED A SECOND TIME AND THE CATHETER PASSED OVER THE GUIDEWIRE READIED FOR THE SECOND ABLATION PASS. WHEN THE ENDOSCOPE WAS POSITIONED PROXIMAL TO THE ELECTRODE BEFORE TREATMENT, THE SURGEON NOTED A MUCOSAL LACERATION AT THE GASTROESOPHAGEAL JUNCTION SUGGESTIVE OF A PERFORATION. THE ABLATION DEVICES WERE REMOVED AND A COVERED STENT PLACED AT THIS SITE. THE PHYSICIAN INDICATED THAT THE GUIDEWIRE MAY HAVE MOVED PROXIMALLY PRIOR TO PASSAGE OF THE CATHETER, THUS RESULTING IN TRAUMA AT THE JUNCTION. A CT SCAN SHOWED INTRA-ABDOMINAL AIR, WITH NO AIR IN THE MEDIASTINUM. THE SURGEON PERFORMED A FUNDOPLICATION. THE PATIENT DID WELL AND WAS DISCHARGED TO HOME ON DAY 7. THERE WAS NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL INC. 32041-22 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R