BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZ SUPER STIFF

    MDR report key: 24214442 · Received January 29, 2026

    Report

    Report Number
    2124215-2026-05326
    Event Type
    Death
    Date Received
    January 29, 2026
    Date of Event
    February 1, 2019
    Report Date
    April 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. B3: DATE OF EVENT: ESTIMATED. E1: INITIAL REPORTER FACILITY NAME: (B)(6); REPORTED HERE AS THE FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. 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. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A REVIEW OF THE AMPLATZ DEVICE CONFIRMED THAT THE REPORTED EVENTS ARE KNOWN EVENTS DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    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. B3: DATE OF EVENT: ESTIMATED. E1: INITIAL REPORTER FACILITY NAME: (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT CHOLANGITIS AND SEPSIS OCCURRED TWO DAYS AFTER THE PROCEDURE, AND THE PATIENT ULTIMATELY PASSED AWAY. 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 NOTED TO BE 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 PATIENTS CONDITION PROGRESSIVELY WORSENED IN THE DAYS LEADING UP TO THE PROCEDURE. DURING THE PROCEDURE, TWO WIRES (0.035IN X 145 CM AMPLATZ SUPER STIFF) WERE INSERTED INTO THE TIPS OF THE DUODENUM. THE SHEATH WAS REMOVED AND REINSERTED OVER ONE OF THE WIRES, AND SUBSEQUENTLY, THE WIRE AND PREVIOUSLY PLACED DILATATOR WERE REMOVED. THIS LEFT THE SHEATH FOR THE SPYSCOPE (BOSTON SCIENTIFIC) AND ONE WIRE AS A SAFETY WIRE, WHICH ALSO DOUBLED AS A GUIDANCE WIRE. THIS PATIENT DEVELOPED CHOLANGITIS AND SEPSIS TWO 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

    IT WAS REPORTED VIA LITERATURE THAT CHOLANGITIS AND SEPSIS OCCURRED TWO DAYS AFTER THE PROCEDURE, AND THE PATIENT ULTIMATELY PASSED AWAY. 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 NOTED TO BE ALREADY IN VERY POOR CLINICAL CONDITION, EXPERIENCED FURTHER DETERIORATION AFTER UNDERGOING S-PTCS. THE PATIENT HAD S-PTCS PERFORMED IN THE PALLIATIVE PHASE, AND THE PATIENTS CONDITION PROGRESSIVELY WORSENED IN THE DAYS LEADING UP TO THE PROCEDURE. DURING THE PROCEDURE, TWO WIRES (0.035IN X 145 CM AMPLATZ SUPER STIFF) WERE INSERTED INTO THE TIPS OF THE DUODENUM. THE SHEATH WAS REMOVED AND REINSERTED OVER ONE OF THE WIRES, AND SUBSEQUENTLY, THE WIRE AND PREVIOUSLY PLACED DILATATOR WERE REMOVED. THIS LEFT THE SHEATH FOR THE SPYSCOPE (BOSTON SCIENTIFIC) AND ONE WIRE AS A SAFETY WIRE, WHICH ALSO DOUBLED AS A GUIDANCE WIRE. THIS PATIENT DEVELOPED CHOLANGITIS AND SEPSIS TWO 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
    269068 AMPLATZ SUPER STIFF WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death