BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE

    MDR report key: 6108908 · Received November 17, 2016

    Report

    Report Number
    3005099803-2016-03549
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K140726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED IN THE DISTAL PART OF THE ESOPHAGUS DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2016. THE INDICATION FOR THE PROCEDURE WAS TO TREAT THE PATIENT'S BARRETT'S ESOPHAGUS AND EARLY ESOPHAGEAL CANCER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND ON THE LAST RESECTION, A PERFORATION OCCURRED. THE PERFORATION SITE WAS SUCCESSFULLY CLOSED BY LAPAROSCOPIC SUTURE. IN THE PHYSICIAN'S ASSESSMENT THE PERFORATION IS RELATED TO THE CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE. THE PATIENT WAS HOSPITALIZED FOR FOUR (4) DAYS AND THE PERFORATION WAS REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762539 CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00561600

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention