BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALO360+ SIZING BALLOON

    MDR report key: 3093711 · Received May 1, 2013

    Report

    Report Number
    3004904811-2013-00019
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K093855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HALO360+ SIZING BALLOON CATHETER, MODEL# 3441C, LOT# F1013771 WAS RETURNED AND EVALUATED AS FOLLOWS: A VISUAL INSPECTION OF THE DEVICE NOTED NO REMARKABLE FINDINGS. A SYSTEM TEST WAS PERFORMED AND THE DEVICE WORKED AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    A PT WITH LONG SEGMENT BARRETT'S ESOPHAGUS CONTAINING LOW GRADE DYSPLASIA WAS BROUGHT BACK ON (B)(6) 2013, TO UNDERGO AN RFA (RADIOFREQUENCY ABLATION) PROCEDURE AFTER AN INITIAL RFA ATTEMPT ON (B)(6) 2013. AFTER UNCONSTRAINED READINGS WERE DOCUMENTED AFTER SIZING THE ESOPHAGUS USING TWO DIFFERENT SIZING BALLOON CATHETERS, THE PHYSICIAN ELECTED TO PROCEED WITH ABLATION, WHICH WAS CONSIDERED SUCCESSFUL PER THE PHYSICIAN. THE PT WAS STABLE POST PROCEDURE AND WAS DISCHARGED TO HOME. THE FOLLOWING EVENING AFTER RFA, THE PT PRESENTED TO THE HOSPITAL WITH CHEST PAIN. THE PT WAS ADMITTED TO THE HOSPITAL AND KEPT OVERNIGHT. WORKUPS INCLUDING A CT SCAN AND X-RAY OF THE CHEST SHOWED NO EVIDENCE OF ESOPHAGEAL PERFORATION BUT INSTEAD RIB PAIN, THOUGHT TO BE MUSCULOSKELETAL IN NATURE AND OF UNKNOWN ETIOLOGY. THE PT WAS PRESCRIBED PAIN MEDICATIONS AND DISCHARGED TO HOME THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189700 HALO360+ SIZING BALLOON ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN F1013771

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization HALOFLEX GENERATOR 1190A-115A, S/N (B)(4)