BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR II

    MDR report key: 17165701 · Received June 20, 2023

    Report

    Report Number
    3005099803-2023-03150
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 1, 2018
    Report Date
    June 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: IT WAS REPORTED THAT THE PROCEDURES WERE BETWEEN (B)(6) 2018 AND (B)(6) 2020. BLOCK D4, H4: THE SUSPECT DEVICE UPN AND LOT NUMBER IS NOT REPORTED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK E1: (INITIAL REPORTER FACILITY NAME) (B)(6). BLOCK E1: (INITIAL REPORTER PHONE NUMBER) (B)(6). BLOCK G3: LITERATURE SOURCE TAKAHARA, N., TSUJI, Y., NAKAI, Y., SUZUKI, Y., INOKUMA, A., KANAI, S., NOGUCHI, K., SATO, T., HAKUTA, R., ISHIGAKI, K., SAITO, K., SAKAGUCHI, Y., SAITO, T., HAMADA, T., MIZUNO, S., KOGURE, H., & KOIKE, K. (2020). A NOVEL TECHNIQUE OF ENDOSCOPIC PAPILLECTOMY WITH HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION FOR AMPULLARY TUMORS: A PROOF-OF-CONCEPT STUDY (WITH VIDEO). JOURNAL OF CLINICAL MEDICINE, 9(8), 2671. HTTPS://DOI.ORG/10.3390/JCM9082671. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONG HOSPITALIZATION. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THROUGH THE ARTICLE "A NOVEL TECHNIQUE OF ENDOSCOPIC PAPILLECTOMY WITH HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION FOR AMPULLARY TUMORS: A PROOF-OF-CONCEPT STUDY" WRITTEN BY NAMINATSU TAKAHARA, ET AL. ACCORDING TO THE LITERATURE, EIGHT CONSECUTIVE PATIENT WHO UNDERWENT HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION-ENDOSCOPIC PAPILLECTOMY (HYBRID ESD-EP) FOR AN AMPULLARY ADENOMA AT THE UNIVERSITY OF TOKYO HOSPITAL BETWEEN MAY 2018 AND MARCH 2020 WERE RETROSPECTIVELY EVALUATED FOR THIS STUDY. HYBRID ESD-EP INVOLVED A (SUB)CIRCUMFERENTIAL INCISION WITH PARTIAL SUBMUCOSAL DISSECTION, AND SUBSEQUENT SNARE RESECTION OF AMPULLARY TUMORS USING A CAPTIVATOR SNARE. IT WAS REPORTED THAT A PATIENT DEVELOPED MODERATE PANCREATITIS THE DAY AFTER THE PROCEDURE. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462948 CAPTIVATOR II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R