BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1981032 · Received February 2, 2011

    Report

    Report Number
    3004904811-2011-00001
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    September 5, 2007
    Report Date
    April 26, 2010
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE NEXUS BETWEEN THE DEVICE AND THE PATIENT'S SUBSEQUENT COMPLICATIONS HAVE NOT BEEN CONFIRMED, BARRX IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 C.F.R. PART 803.

    Description of Event or Problem · 1

    A PATIENT WITH A 6 CM BARRETT'S ESOPHAGUS WAS TREATED WITH CIRCUMFERENTIAL ABLATION WITHOUT ACUTE ADVERSE EVENT. THERE WAS NO REPORTED DEVICE MALFUNCTION ACCORDING TO THE ENDOSCOPY REPORT. THE PATIENT REPORTED DIFFICULTY SWALLOWING AND WAS ADMITTED FOR EVALUATION 13 DAYS AFTER INITIAL TREATMENT. UPPER ENDOSCOPY SHOWED AN ULCERATED DISTAL ESOPHAGUS WITH ADHERENT COAGULUM, WHICH WAS DEBRIDED WITH SNARE EXCISION FOLLOWED BY USE OF THE BIOPSY FORCEPS TO REMOVE ALL ABNORMAL APPEARING TISSUE. THE PATIENT REPORTED IMPROVED SYMPTOMS AND WAS DISCHARGED THE NEXT DAY. BARRX WAS NOTIFIED APPROXIMATELY 3 YEARS LATER THAT A LAWSUIT WAS FILED AGAINST THE (B)(6) AND THE TREATING PHYSICIAN (NOT THE MANUFACTURER) REGARDING A NUMBER OF SUBSEQUENT EVENTS, INCLUDING STRICTURE FORMATION, ESOPHAGECTOMY, AND GASTRIC EMPTYING ABNORMALITIES AFTER SURGERY. AS A RESULT OF THIS LAWSUIT, THE COMPANY RECEIVED PORTIONS OF THE MEDICAL RECORD OF THIS PATIENT FROM HIS ATTORNEY. THESE REPORTS INDICATE THAT THE PATIENT DEVELOPED A STRICTURE IN THE DISTAL ESOPHAGUS AT SOME POINT SUBSEQUENT TO THE ENDOSCOPIC DEBRIDEMENT PROCEDURE, ALTHOUGH THERE WAS NO TIME COURSE NOTED. THEREFORE, IT IS UNCLEAR WHETHER THE REPORTED STRICTURE OCCURRED AS A RESULT OF THE ABLATION INDUCED ULCERATION OR DEBRIDEMENT OF TISSUE AFTER ABLATION. ACCORDING TO THE LAWSUIT, THE TREATING PHYSICIAN IS NOT AVAILABLE FOR COMMENT. ACCORDING TO THE LAWSUIT, THE PATIENT'S STRICTURE WAS REFRACTORY TO DILATION AND STENTING, AND THE PATIENT THEREFORE UNDERWENT AN ESOPHAGECTOMY. THE LAWSUIT FURTHER ALLEGES GASTRIC EMPTYING ABNORMALITIES AFTER SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R