BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE

    MDR report key: 6427025 · Received March 23, 2017

    Report

    Report Number
    3005099803-2017-00755
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 22, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K140726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS UNDER CLINICAL STUDY 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 ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL TRIAL. ON (B)(6) 2017, THE PATIENT WAS CONFIRMED OF HAVING A BARRETT'S ESOPHAGUS WITH VISIBLE ABNORMALITY. THE INDICATION FOR THE EMR PROCEDURE WAS HIGH-GRADE DYSPLASIA (HGD) IN FOCAL LESION. THE PATIENT REQUIRED DISCONTINUATION OF ANTICOAGULANT THERAPY. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 35 CM FROM THE DENTAL ARCH AT 5 O¿CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 7 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 30%. THE LESION APPEARED SUPERFICIAL, ELEVATED (0-IIA). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. FOUR RESECTIONS WERE PERFORMED AND IMMEDIATELY AFTER LESION RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. LIFTING WAS NOT PERFORMED. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH THE CAPTIVATOR EMR CAP/SNARE. FORMALIN WAS USED TO PROCESS RETRIEVED RESECTION SPECIMENS. ONE SPECIMEN WAS RETRIEVED AND HISTOLOGY SHOWED CANCER. INFILTRATION DEPTH WAS T1M1 AND RADICALITY OF DEEP RESECTION MARGINS WAS R0. TUMOR DIFFERENTIATION DATA HAS NOT BEEN REPORTED YET. LYMPHOVASCULAR INVASION WAS NOT PRESENT. ON (B)(6) 2017, AN ESOPHAGEAL DYSPHAGIA WAS NOTED AND WAS TREATED WITH CARAFATE. THE DYSPHAGIA WAS CONSIDERED NON-SERIOUS AND MILD, AND RELATED TO THE CAPTIVATOR EMR DEVICE AND PROCEDURE. THE OUTCOME OF THE EVENT WAS REPORTED TO BE RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210546 CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00561600 19880959

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention