BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOFLEX (115V) GENERATOR

    MDR report key: 3063437 · Received April 12, 2013

    Report

    Report Number
    3004904811-2013-00016
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    COVIDIEN/BARRX
    Product Code
    GEI
    PMA / PMN Number
    K092487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: THE HALOFLEX GENERATOR WAS RETURNED FOR ANALYSIS. THE GENERATOR FUNCTIONED PROPERLY AND PASSED ALL INSPECTIONS AND FUNCTIONAL TESTING. THE GENERATOR DISPLAYS THE MESSAGE "UNCONSTRAINED" IF THE PT ESOPHAGUS SIZE MEASURES GREATER THAN 37MM, AS NOTED IN DATA DOWNLOADED FROM THE GENERATOR. (B)(4).

    Description of Event or Problem · 1

    A PT WITH LONG SEGMENT BARRETT'S ESOPHAGUS CONTAINING LOW GRADE DYSPLASIA UNDERWENT ENDOSCOPY WITH INTENT TO DELIVER CIRCUMFERENTIAL ABLATION. PER THE INSTRUCTIONS FOR USE FOR THE DEVICE, A SIZING BALLOON WAS USED FIRST TO MEASURE THE INNER DIAMETER OF THE ESOPHAGUS. PER THE PHYSICIAN REPORT, THE SIZING MEASUREMENTS AS DISPLAYED BY THE GENERATOR WERE LARGER THAN ANTICIPATED BY THE PHYSICIAN, SO THE PHYSICIAN REPEATED SIZING WITH A NEW SECOND SIZING BALLOON WHICH YIELDED THE SAME RESULTS. THE PHYSICIAN REPORTED THAT HE DID NOT FEEL COMFORTABLE THAT THE SIZING MEASUREMENTS ACCURATELY REFLECTED THE INNER DIAMETER OF THE PT'S ESOPHAGUS, THEREFORE, HE ELECTED TO DISCONTINUE THE CASE AND NOT PROVIDE ABLATION TREATMENT. APPROX ONE MONTH LATER, THE PT WAS BROUGHT BACK FOR A SECOND ENDOSCOPY WHERE TWO NEW SIZING BALLOONS DISPLAYED SIMILAR (LARGE) MEASUREMENTS OF THE ESOPHAGUS AS SEEN IN THE FIRST CASE. THIS TIME, THE PHYSICIAN ELECTED TO TREAT WITH CIRCUMFERENTIAL ABLATION WITHOUT ANY RELATED ACUTE ADVERSE EVENTS. AS A RESULT OF THIS PHYSICIAN REPORT OF HIS UNCERTAINTY OF THE ACCURACY OF THE SIZING BALLOONS (4) USED IN THIS PT ON TWO OCCASIONS, THE MFR REQUESTED RETURN OF THE AVAILABLE SIZING BALLOONS (LAST TWO WERE AVAILABLE) AND THE GENERATOR FOR A FULL INSPECTION. THE GENERATOR FUNCTIONED PROPERLY ON TESTING AND PASSED ALL INSPECTIONS AND FUNCTIONAL TESTING. DATA FROM THE CATHETERS AND GENERATOR FOR THIS PARTICULAR CASE SHOWED THE ESOPHAGUS TO BE 36-38 MM IN INNER DIAMETER, SUGGESTING A POORLY COMPLIANT ESOPHAGEAL BODY OR DILATION OF THE ESOPHAGEAL BODY, AN ANATOMIC VARIANT. THE DEVICES WORKED PROPERLY AND DID NOT MALFUNCTION. THE MFR IS REPORTING THIS COMPLAINT OUT OF AN ABUNDANCE OF CAUTION EVEN THOUGH THERE WAS NO PRODUCT MALFUNCTION OR DEFECT, BECAUSE THE PHYSICIAN DISCONTINUED THE FIRST CASE DUE TO UNCERTAINTY ABOUT THE ACCURACY OF THE SIZING BALLOON MEASUREMENTS AND THE PROCEDURE HAD TO BE REPEATED AT A LATER DATE. THE PHYSICIAN HAS BEEN CONTACTED BY THE MFR TO PROVIDE INFO ABOUT THE FUNCTIONALITY OF THE GENERATOR AND SIZING BALLOON AS IT PERTAINS TO ANATOMIC VARIANTS SEEN IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158126 HALOFLEX (115V) GENERATOR ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN/BARRX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HALO360+ SIZING BALLOON: CAT# 3441C,| LOT# F1013473| HALO360+ 31MM ABLATION CATHETER: CAT#32041-31,| LOT #F1013771