BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE

    MDR report key: 17129121 · Received June 14, 2023

    Report

    Report Number
    3005099803-2023-03158
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 1, 2015
    Report Date
    July 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729156659
    PMA / PMN Number
    K131700
    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 FROM MAY 2015 TO MAY 2016. BLOCK G3: LITERATURE SOURCE JOURNAL ARTICLE: ITO T, ET AL. "SAFETY AND EFFICACY OF COLD SNARE POLYPECTOMY FOR SMALL COLORECTAL POLYPS: A PROSPECTIVE RANDOMIZED CONTROL TRIAL AND ONE-YEAR FOLLOW-UP STUDY." MEDICINE 2021;100:23(E26296). BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE MAJOR 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

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE MAJOR. 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. IMDRF DEVICE CODE A24 CAPTURES THE REPORTABLE EVENT OF ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THROUGH THE ARTICLE "SAFETY AND EFFICACY OF COLD SNARE POLYPECTOMY FOR SMALL COLORECTAL POLYPS" WRITTEN BY TAKAHIRO ITO, ET AL. ACCORDING TO THE LITERATURE, 119 PATIENTS WERE RECRUITED FOR THIS STUDY AND UNDERWENT POLYPECTOMY AT ASAHIKAWA-KOUSEI GENERAL HOSPITAL FROM MAY 2015 TO MAY 2016. THE PARTICIPANTS WERE RANDOMIZED, WITH 59 PATIENTS ASSIGNED TO THE COLD SNARE POLYPECTOMY GROUP. A TOTAL OF 458 POLYPS WERE RESECTED FROM THE PARTICIPANTS OF BOTH GROUPS. COLD SNARE POLYPECTOMY WAS PERFORMED WITH A SMALL OVAL FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE OR A MEDIUM FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE. IT WAS REPORTED THAT A PATIENT HAD DELAYED BLEEDING REQUIRING INTERVENTION. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THROUGH THE ARTICLE "SAFETY AND EFFICACY OF COLD SNARE POLYPECTOMY FOR SMALL COLORECTAL POLYPS" WRITTEN BY TAKAHIRO ITO, ET AL. ACCORDING TO THE LITERATURE, 119 PATIENTS WERE RECRUITED FOR THIS STUDY AND UNDERWENT POLYPECTOMY AT (B)(6) HOSPITAL FROM (B)(6) 2015 TO (B)(6) 2016. THE PARTICIPANTS WERE RANDOMIZED, WITH 59 PATIENTS ASSIGNED TO THE COLD SNARE POLYPECTOMY GROUP. A TOTAL OF 458 POLYPS WERE RESECTED FROM THE PARTICIPANTS OF BOTH GROUPS. COLD SNARE POLYPECTOMY WAS PERFORMED WITH A SMALL OVAL FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE OR A MEDIUM FLEXIBLE BOSTON SCIENTIFIC PROFILE SNARE. IT WAS REPORTED THAT A PATIENT HAD DELAYED BLEEDING REQUIRING INTERVENTION. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830756 PROFILE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00562551 08714729156659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention