BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRX CHANNEL RFA ENDOSCOPIC CATHETER

    MDR report key: 6037998 · Received October 18, 2016

    Report

    Report Number
    3004904811-2016-00083
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    SUNNYVALE
    Product Code
    GEI
    PMA / PMN Number
    K130623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE USED DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL INSPECTION FOUND THAT THE ELECTRODE HAD TORN AND THEN CAME OFF THE PATTY. THE INVESTIGATION ISOLATED THE FAILURE TO THE DAMAGED ELECTRODE, BUT A ROOT CAUSE COULD NOT BE IDENTIFIED. THE FAILURE IS CONSISTENT WITH SOME TYPE OF EXTERNAL OBJECT DAMAGING THE ELECTRODE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED LOT/SERIAL NUMBER WAS COMPLETED AND NO ENTRIES PERTINENT TO THE EVENT WERE NOTED AND THIS LOT/SERIAL NUMBER WAS RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN PERFORMING THE FIRST SET OF ABLATIONS, THE ELECTRODES CAME OFF THE PROBE (APPROXIMATELY 25%). ELECTRODES WERE STILL ATTACHED TO THE PATIENT'S ESOPHOGUS. TO CORRECT THE CONDITION, THE DOCTOR REMOVED THE REMAINING ELECTRODES USING A BIOSPY FORSEPTS. PATIENT HAD A NORMAL RECOVERY. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND UNDER ANESTHESIA. THE PATIENT DID NOT EXPERIENCE ANY INJURY SUCH AS PERFORATION, STRICTURE, OR BLEEDING. THE USER ALSO DID NOT EXPERIENCE ANY INJURY. SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO OR FIRE. PATIENT GENDER, AGE, WEIGHT, AND COMORBIDITIES COULD NOT BE PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688112 BARRX CHANNEL RFA ENDOSCOPIC CATHETER BARRX CHANNEL RFA ENDOSCOPIC CATHETER GEI SUNNYVALE TTS-1100 F2501015X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention