SPYSCOPE DS II ACCESS & DELIVERY CATHETER
Report
- Report Number
- 3005099803-2025-06819
- Event Type
- Death
- Date Received
- December 22, 2025
- Date of Event
- January 1, 2016
- Report Date
- March 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FBN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: DEPARTMENT OF SURGERY AND TRANSPLANTATION, RIGSHOSPITALET. 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.
BLOCKS B2 (DATE OF DEATH), B5 (EVENT), B7 (OTHER RELEVANT HISTORY), AND G2 (REPORT SOURCE) HAVE BEEN CORRECTED BASED ON THE REVIEW OF THE COMPLAINT RECORD ON JANUARY 26, 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.
BLOCKS B2 (DATE OF DEATH), B5 (EVENT), B7 (OTHER RELEVANT HISTORY), AND G2 (REPORT SOURCE) 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: DEPARTMENT OF SURGERY AND TRANSPLANTATION, RIGSHOSPITALET 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. BLOCK H11: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES, THAT THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, A MEDIA INSPECTION WAS COMPLETED. THE ARTICLE SHOWED A PROCEDURE PERFORMED WITH THE SPYGLASS VISUALIZATION DEVICES; HOWEVER, NO DAMAGE TO THE DEVICE OR PROCEDURAL COMPLICATIONS RELATED TO THE DEVICE WERE OBSERVED. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. ADDITIONALLY, CHOLANGITIS AND SEPSIS ARE NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. A REVIEW OF THE SPYSCOPE DS II ACCESS AND DELIVERY CATHETER HAZARD ANALYSIS WAS COMPLETED AND CONFIRMED THAT THE EVENT OF SEPSIS, CHOLANGITIS AND DEATH WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE AVAILABLE INFORMATION AND IN THE ABSENCE OF DEVICE RETURN, THE ROOT CAUSE OF THE REPORTED CLINICAL OBSERVATIONS IS UNABLE TO EXCLUDE DEVICE PROBLEM.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2282377 | SPYSCOPE DS II ACCESS & DELIVERY CATHETER | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FBN | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |