BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

    MDR report key: 21447062 · Received February 24, 2025

    Report

    Report Number
    3005099803-2025-00547
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    July 1, 2022
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE ARTICLE WAS SUBMITTED. BLOCK D4, H4: THE DEVICE UPN AND LOT NUMBER ARE UNKNOWN; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: CLINICAL JOURNAL OF GASTROENTEROLOGY (2022) 15:1179-1184 HTTPS://DOI.ORG/10.1007/S12328-022-01699-1 A CASE OF ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY-RELATED MAIN PANCREATIC DUCT PERFORATION SALVAGED BY ENDOSCOPICULTRASONOGRAPHY-GUIDED PANCREATIC DUCT DRAINAGE RYOSUKE SATO, KAZUYUKI MATSUMOTO, AKIHIRO MATSUMI, KOSAKU MORIMOTO, HIROYUKI TERASAWA, YUKI FUJII, TATSUHIRO YAMAZAKI, KOICHIRO TSUTSUMI, SHIGERU HORIGUCHI, HIRONARI KATO. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF MPD PERFORATION. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E1102 CAPTURES THE REPORTABLE EVENT OF EPIGASTRIC PAIN. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM THROUGH THE ARTICLE, A CASE OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY-RELATED MAIN PANCREATIC DUCT PERFORATION SALVAGED BY ENDOSCOPIC ULTRASONOGRAPHY-GUIDED PANCREATIC DUCT DRAINAGE BY RYOSUKE SATO, ET AL. PER THE ARTICLE, DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE CYTOLOGY BRUSH CATHETER WAS INSERTED, AND THE MAIN PANCREATIC DUCT (MPD) AT THE PANCREATIC HEAD WAS DISRUPTED. CONTRAST MATERIAL LEAKED FROM THE PANCREAS. THE PATIENT WAS DIAGNOSED WITH MPD PERFORATION. A NON BSC PLASTIC STENT WAS PLACED NEAR THE PERFORATED SITE BECAUSE THE GUIDEWIRE COULD NOT BE INSERTED INTO THE DISTAL SIDE OF THE PERFORATED SITE. ABDOMINAL COMPUTED TOMOGRAPHY (CT) IMMEDIATELY AFTER ERCP SHOWED THE LEAKAGE OF CONTRAST MATERIAL INTO THE RETROPERITONEUM. FOLLOW-UP CT REVEALED RETROPERITONEAL AIR AND PERIPANCREATIC FAT INFLAMMATION, WHICH INDICATED RETROPERITONEAL PERFORATION AND ACUTE PANCREATITIS THREE DAYS AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO OKAYAMA UNIVERSITY HOSPITAL. ABDOMINAL EXAMINATION SHOWED EPIGASTRIC PAIN. A BLOOD EXAMINATION SHOWED THAT THE INFLAMMATORY MARKERS, SERUM PANCREATIC ENZYME, AND ELECTROLYTE VALUES WERE ABNORMAL. ERCP AND AN ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DUCT DRAINAGE (EUS-PD) PROCEDURE WAS PERFORMED. SUBSEQUENTLY, THE PATIENT GRADUALLY IMPROVED AND WAS DISCHARGED 3 MONTHS AFTER INITIAL ERCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402283 COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H