BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE

    MDR report key: 6031630 · Received October 14, 2016

    Report

    Report Number
    3005099803-2016-03079
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    July 5, 2016
    Report Date
    September 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K140726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 19, 2016 THAT A CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED ON (B)(6) 2016 AS PART OF THE (B)(6) TRIAL. ON (B)(6) 2016, THE PATIENT WAS CONFIRMED OF HAVING A BARRETT'S ESOPHAGUS WITH VISIBLE ABNORMALITY. THE INDICATION FOR ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE WAS HIGH-GRADE DYSPLASIA (HGD) IN FOCAL LESION AND EARLY ESOPHAGEAL ADENOCARCINOMA. THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 38 CM FROM THE DENTAL ARCH AT 2 O¿CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 10 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 100%. THE LESION APPEARED FLAT (0-IIB). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. FIVE (5) RESECTIONS WERE PERFORMED AND AN ENDOSCOPIC IMAGING WAS PERFORMED IMMEDIATELY AFTERWARDS. LIFTING WAS PERFORMED WITH SALINE SOLUTION AND ADRENALINE. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH A RETRIEVAL NET. ON THE SAME DAY, THE PATIENT EXPERIENCED PAIN AND PERFORATION WHICH WERE CONSIDERED SERIOUS AND MODERATE BUT WAS NOT RELATED TO THE CAPTIVATOR¿ EMR DEVICE BUT WAS RELATED TO THE EMR PROCEDURE. THE PATIENT'S PAIN WAS TREATED WITH ACETAMINOPHEN AND OXYCODONE MEDICATIONS WHILE THE PATIENT'S PERFORATION WAS TREATED WITH PIPERACILLIN/TAZOBACTAM AND AMOXICILLIN/CLAVULANATE WHILE THE PATIENT HAD A PROLONGED HOSPITAL STAY. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME OF THE EVENT WAS REPORTED TO BE RESOLVED.

    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 ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE WAS HIGH-GRADE DYSPLASIA (HGD) IN FOCAL LESION AND EARLY ESOPHAGEAL ADENOCARCINOMA. THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 38 CM FROM THE DENTAL ARCH AT 2 O¿CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 10 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 100%. THE LESION APPEARED FLAT (0-IIB). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. FIVE (5) RESECTIONS WERE PERFORMED AND AN ENDOSCOPIC IMAGING WAS PERFORMED IMMEDIATELY AFTERWARDS. LIFTING WAS PERFORMED WITH SALINE SOLUTION AND ADRENALINE. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH A RETRIEVAL NET. ON THE SAME DAY, THE PATIENT EXPERIENCED PAIN AND PERFORATION WHICH WERE CONSIDERED SERIOUS AND MODERATE BUT WAS NOT RELATED TO THE CAPTIVATOR¿ EMR DEVICE BUT WAS RELATED TO THE EMR PROCEDURE. THE PATIENT'S PAIN WAS TREATED WITH ACETAMINOPHEN AND OXYCODONE MEDICATIONS WHILE THE PATIENT'S PERFORATION WAS TREATED WITH PIPERACILLIN/TAZOBACTAM AND AMOXICILLIN/CLAVULANATE WHILE THE PATIENT HAD A PROLONGED HOSPITAL STAY. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME OF THE EVENT WAS REPORTED TO BE RESOLVED. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 28, 2016. THE PATIENT EXPERIENCED PERFORATION IN THE EMR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680556 CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00561610 19200533

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization