BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 4791594 · Received May 22, 2015

    Report

    Report Number
    3004904811-2015-00008
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 22, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K062723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INDICATED TAHT THE INCIDENT UNIT WOULD NOT BE RETURNING FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT OT THE INCIDENT IS OBATAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT RADIOFREQUENCY ABLATION (RFA) AS A PARTICIPANT IN THE B-600 RGB SALVAGE STUDY ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT REPORTED VOMITING WITH BLOOD AND MELENA. VOMITING STOPPED AFTER PATIENT WAS PRESCRIBED ZOFRAN. THE TREATING PHYSICIAN PERFORMED AN UPPER ENDOSCOPY (EGD) ON (B)(6) 2015. THE EGD REVEALED THAT THE STOMACH WAS MOSTLY HEALED BUT AN ADHERENT CLOT IN THE GASTRIC POUCH WAS SEEN WITH SUPERFICIAL GASTRIC ULCERS. THIS WAS TREATED WITH COAPTIVE COAGULATION AND AN EPINEPHRINE INJECTION. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL FOR OBSERVATION WHERE SHE REMAINED FOR SIX DAYS. PATIENT WAS THEN SEEN BY HER PRIMARY CARE DOCTOR ON (B)(6) 2015 DUE TO ONGOING FATIGUE. GUAIAC TEST BY PCP WAS POSITIVE AND PATIENT REFERRED TO EMERGENCY DEPARTMENT (ED). PATIENT STABLE PER ED PHYSICIAN AND SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336708 HALO90 ABLATION CATHETER ELECTROSURGICAL COAGLUTION SYSTEM GEI COVIDIEN 90-9100 F1014411

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization