BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 17170085 · Received June 21, 2023

    Report

    Report Number
    3005099803-2023-03269
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K183636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 (DATE OF EVENT): DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2023 AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6 (PATIENT CODES): IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF IMPACT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT THE 105TH ANNUAL MEETING OF THE JAPANESE SOCIETY FOR GASTROINTESTINAL ENDOSCOPY (JGES) A RETROSPECTIVE REVIEW OF 35 CASES AND 47 PROCEDURES (26 MALES AND 9 FEMALES, MEDIAN AGE 68 (22-86) YEARS) USING ORAL PANCREATOSCOPE (POPS) FROM (B)(6) 2017 TO (B)(6) 2022 WAS PERFORMED TO DETERMINE PANCREATIC STONE TREATMENT OUTCOMES AND ASSOCIATED FACTORS. THE SPYSCOPE DS II WAS USED FOR THESE PROCEDURES. THE REVIEW FOUND EIGHT CASES OF PANCREATITIS, TWO CASES OF CHOLANGITIS, ONE CASE OF PERFORATION, AND ONE CASE OF HEMORRHAGE. TWELVE CASES WERE FOUND TO HAVE AN INCIDENTAL COMPLICATION AND ONE CASE RESULTED IN EMERGENCY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252109 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention