BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYBITE

    MDR report key: 23879693 · Received December 23, 2025

    Report

    Report Number
    3005099803-2025-06845
    Event Type
    Death
    Date Received
    December 23, 2025
    Date of Event
    January 1, 2016
    Report Date
    February 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B2 (DATE OF DEATH), AND B5 (EVENT) HAVE BEEN CORRECTED BASED ON THE REVIEW OF THE COMPLAINT RECORD ON (B)(6) 2026. BLOCK B3: APPROXIMATED BASED ON THE DATE THE ARTICLE WAS CONDUCTED. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK G2: LITERATURE SOURCE: ULVUND SOLSTAD, T., ET AL. "CHOLANGIOSCOPY WITH SPYGLASS DS USING PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY ACCESS: A RETROSPECTIVE COHORT STUDY." ANNALS OF MEDICINE &SURGERY (2024). HTTP://DX.DOI.ORG/1097/MS9.0000000000001840. BLOCK H6: IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT DEATH.

    Additional Manufacturer Narrative · 0

    BLOCK B2: THE EXACT DATE OF THE PATIENTS' DEATH WAS NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF JANUARY 1, 2016, IS USED FOR THE ESTIMATED DATE OF DEATH. BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF JANUARY 1, 2016, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 1, 2016, AND DECEMBER 31, 2021. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER FACILITY NAME: DEPARTMENT OF SURGERY AND TRANSPLANTATION, RIGSHOSPITALET; REPORTED HERE AS THE HEALTHCARE FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: TRYGVE ULVUND SOLSTAD, MORTEN THORSTEINSSON, NICOLAI SCHULTZ, PETER NORGAARD LARSEN, MIKKEL TAUDORF, MICHAEL ACHIAM. "CHOLANGIOSCOPYWITH SPYGLASS DS USING PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY ACCESS: A RETROSPECTIVE COHORT STUDY" DEPARTMENT OF SURGERY AND TRANSPLANTATION, RIGSHOSPITALET, KOBENHAVN O, DENMARK, HTTP://DX.DOI.ORG/1097/MS9.0000000000001840. BLOCK H6: IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A SPYBITE BIOPSY FORCEPS USED WITH SPYSCOPE DS II AND TWO AMPLATZ SUPER STIFF DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING TWO AMPLATZ SUPER STIFF, SPYSCOPE DS II AND SPYBITE BIOPSY FORCEPS THROUGH THE ARTICLE TITLED "CHOLANGIOSCOPY WITH SPYGLASS DS USING PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY ACCESS: A RETROSPECTIVE COHORT STUDY" BY ULVUND SOLSTAD, T., ET AL. THE STUDY WAS DESIGNED TO RETROSPECTIVELY EVALUATE THE USE OF PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY WITH SPYGLASS DS TECHNOLOGY (S-PTCS) OVER A FIVE-YEAR PERIOD AT A DANISH TERTIARY REFERRAL CENTER. ACCORDING TO THE ARTICLE, BETWEEN 2016 AND 2021, PATIENTS WHO HAD UNDERGONE UPPER GASTROINTESTINAL AND HEPATO-PANCREATO-BILIARY SURGERY OR TRANSPLANTATION WERE INCLUDED IN THE STUDY AND SUBSEQUENTLY UNDERWENT S-PTCS. THESE PROCEDURES WERE PERFORMED IN CASES OF SUSPECTED STENOSIS OR OTHER PATHOLOGIES WITHIN THE BILE-DUCT SYSTEM, PARTICULARLY WHEN CONVENTIONAL ERCP OR PERORAL CHOLANGIOSCOPY WERE NOT FEASIBLE. IN TOTAL, 22 PATIENTS WERE INCLUDED IN THE STUDY. 21 OUT OF THE 22 PATIENTS DID NOT REPORT ANY COMPLICATIONS. ONE PATIENT, WHO WAS ALREADY IN VERY POOR CLINICAL CONDITION, EXPERIENCED FURTHER DETERIORATION AFTER UNDERGOING S-PTCS. REPORTEDLY, THE PATIENT HAD PRIOR CO-MORBIDITIES OF: UNEXPLAINED JAUNDICE, POST-LIVER TRANSPLANT; ISCHEMIA AND ATROPHY IN THE BILE DUCTS. "THE PATIENT HAD S-PTCS PERFORMED IN THE PALLIATIVE PHASE, AND THE PATIENT'S CONDITION PROGRESSIVELY WORSENED IN THE DAYS LEADING UP TO THE PROCEDURE. THIS PATIENT DEVELOPED CHOLANGITIS AND SEPSIS 2 DAYS AFTER S-PTCS, WHICH LIKELY OCCURRED BECAUSE OF INSTRUMENTATION IN THE BILIARY TRACT. HOWEVER, THE PATIENT WAS ALREADY IN A MORIBUND STATE, AND S-PTCS WAS PERFORMED WITH PALLIATIVE INTENT, WHICH MADE INTERVENTION WITH S-PTCS THE PREFERABLE OPTION." THE PATIENT ULTIMATELY DIED 14 DAYS LATER. THERE WERE NO REPORTED PROBLEMS WITH THE TWO AMPLATZ SUPER STIFF, SPYSCOPE DS II OR SPYBITE BIOPSY FORCEPS.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND SPYBITE BIOPSY FORCEPS DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING THE SPYSCOPE DS II AND SPYBITE BIOPSY FORCEPS THROUGH THE ARTICLE TITLED "CHOLANGIOSCOPY WITH SPYGLASS DS USING PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY ACCESS: A RETROSPECTIVE COHORT STUDY" BY ULVUND SOLSTAD, T., ET AL. THE STUDY WAS DESIGNED TO RETROSPECTIVELY EVALUATE THE USE OF PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY WITH SPYGLASS DS TECHNOLOGY (S-PTCS) OVER A FIVE-YEAR PERIOD AT A DANISH TERTIARY REFERRAL CENTER. ACCORDING TO THE ARTICLE, BETWEEN 2016 AND 2021, PATIENTS WHO HAD UNDERGONE UPPER GASTROINTESTINAL AND HEPATO-PANCREATO-BILIARY SURGERY OR TRANSPLANTATION WERE INCLUDED IN THE STUDY AND SUBSEQUENTLY UNDERWENT S-PTCS. THESE PROCEDURES WERE PERFORMED IN CASES OF SUSPECTED STENOSIS OR OTHER PATHOLOGIES WITHIN THE BILE-DUCT SYSTEM, PARTICULARLY WHEN CONVENTIONAL ERCP OR PERORAL CHOLANGIOSCOPY WERE NOT FEASIBLE. IN TOTAL, 22 PATIENTS WERE INCLUDED IN THE STUDY. 21 OUT OF THE 22 PATIENTS DID NOT REPORT ANY COMPLICATIONS. ONE PATIENT, WHO WAS ALREADY IN VERY POOR CLINICAL CONDITION, EXPERIENCED FURTHER DETERIORATION AFTER UNDERGOING S-PTCS. REPORTEDLY, THE PATIENT HAD PRIOR CO-MORBIDITIES OF: UNEXPLAINED JAUNDICE, POST-LIVER TRANSPLANT; ISCHEMIA AND ATROPHY IN THE BILE DUCTS. THE PATIENT HAD S-PTCS PERFORMED IN THE PALLIATIVE PHASE, AND THE PATIENT'S CONDITION PROGRESSIVELY WORSENED IN THE DAYS LEADING UP TO THE PROCEDURE. THIS PATIENT DEVELOPED CHOLANGITIS AND SEPSIS 2 DAYS AFTER S-PTCS, WHICH LIKELY OCCURRED BECAUSE OF INSTRUMENTATION IN THE BILIARY TRACT. HOWEVER, THE PATIENT WAS ALREADY IN A MORIBUND STATE, AND S-PTCS WAS PERFORMED WITH PALLIATIVE INTENT, WHICH MADE INTERVENTION WITH S-PTCS THE PREFERABLE OPTION. THE PATIENT ULTIMATELY DIED 14 DAYS LATER. THERE WERE NO REPORTED PROBLEMS WITH THE SPYSCOPE DS II OR SPYBITE BIOPSY FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828997 SPYBITE FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death