BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE

    MDR report key: 6031673 · Received October 14, 2016

    Report

    Report Number
    3005099803-2016-03024
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    April 28, 2016
    Report Date
    September 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K140726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) CLINICAL TRIAL. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED ON (B)(6) 2016 AS PART OF THE (B)(6) CLINICAL TRIAL. ON (B)(6) 2016, THE PATIENT WAS CONFIRMED OF HAVING A BARRETT'S ESOPHAGUS WITH VISIBLE ABNORMALITY. THE INDICATION FOR THE ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE WAS LOW-GRADE DYSPLAGIA (LGD) IN FOCAL LESION. THE PATIENT REQUIRED DISCONTINUATION OF ANTICOAGULANT THERAPY. ON THE SAME DAY, THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 39 CM FROM THE DENTAL ARCH AT 6 O'CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 15 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 20%. THE LESION APPEARED SUPERFICIAL, ELEVATED (0-IIA). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. TWO (2) RESECTIONS WERE PERFORMED AND AN ENDOSCOPIC IMAGING WAS PERFORMED IMMEDIATELY AFTERWARDS. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH A RETRIEVAL NET. TWO (2) SPECIMENS WERE RETRIEVED AND HISTOLOGY SHOWED CANCER. INFILTRATION DEPTH WAS T1SM1 (<500 UM) AND RADICALITY OF DEEP RESECTION MARGINS WAS R0 (NO INVOLVEMENT OF THE DEEP/VERTICAL RESECTION MARGIN). THERE WAS MODERATE TUMOR DIFFERENTIATION AND LYMPHOVASCULAR INVASION. ON (B)(6) 2016, THE PATIENT PRESENTED WITH BLEEDING WHICH WAS CONSIDERED SERIOUS AND MODERATE BUT WAS NOT RELATED TO THE CAPTIVATOR EMR DEVICE; HOWEVER, IT WAS RELATED TO THE EMR PROCEDURE. THE PATIENT WAS HOSPITALIZED; HEMOSTATIC CLIPPING WAS PERFORMED AND ADRENALINE WAS INJECTED VIA ENDOSCOPY. THE PATIENT ALSO RECEIVED TWO UNITS OF BLOOD VIA TRANSFUSION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME OF THE EVENT WAS REPORTED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681717 CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00561600 18588370

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention