BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZ SUPER STIFF

    MDR report key: 22292363 · Received June 19, 2025

    Report

    Report Number
    2124215-2025-40148
    Event Type
    Death
    Date Received
    June 19, 2025
    Date of Event
    January 1, 2005
    Report Date
    July 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE OF EVENT IS UNKNOWN; THEREFORE, FIRST DAY OF TREATMENT MONTH/YEAR HAS BEEN SELECTED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. 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: MARCH, C., THORMANN, M., HASS, P., GEORGIADES, M., SENSSE, M., HERRMANN, T., OMARI, J., PECH, M., DAMM, R. MORTALITY AND POSTINTERVENTIONAL COMPLICATIONS AFTER ABLATIVE TREATMENT OF LIVER MALIGNANCIES: A COHORT STUDY OF 4374 PATIENTS. BRACHYTHERAPY JOURNAL 23 (2024) 743-750, HTTPS://DOI.ORG/10.1016/J.BRACHY.2024.07.001. BLOCK H6: IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF PERITONITIS. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E050303 CAPTURES THE REPORTABLE EVENT OF PULMONARY EMBOLISM. IMDRF PATIENT CODE E061202 CAPTURES THE REPORTABLE EVENT OF MYOCARDIAL INFARCTION. IMDRF PATIENT CODE E130501CAPTURES THE REPORTABLE EVENT OF RENAL FAILURE. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF PATIENT CODE E0733 CAPTURES THE REPORTABLE EVENT OF PNEUMONIA. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F1901CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2302 CAPTURES THE REPORTABLE EVENT OF BLOOD TRANSFUSION. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO B5 DESCRIBE EVENT OR PROBLEM, D2A COMMON DEVICE NAME, D2B PRO CODE (PRODUCT CODE), G1 MANUFACTURER CONTACT, AND H6 PATIENT CODES, IMPACT CODES, AND EVALUATION CONCLUSION CODES. BLOCK B3: EXACT DATE OF EVENT IS UNKNOWN; THEREFORE, FIRST DAY OF TREATMENT MONTH/YEAR HAS BEEN SELECTED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. 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 NAM: (B)(6). BLOCK G2: LITERATURE SOURCE: MARCH, C., THORMANN, M., HASS, P., GEORGIADES, M., SENSSE, M., HERRMANN, T., OMARI, J., PECH, M., DAMM, R. MORTALITY AND POSTINTERVENTIONAL COMPLICATIONS AFTER ABLATIVE TREATMENT OF LIVER MALIGNANCIES: A COHORT STUDY OF 4374 PATIENTS. BRACHYTHERAPY JOURNAL 23 (2024) 743-750, HTTPS://DOI.ORG/10.1016/J.BRACHY.2024.07.001.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE BRACHYTHERAPY JOURNAL. THE STUDY WAS AIMED TO INVESTIGATE COMPLICATIONS AND MORTALITY AFTER ABLATIVE TREATMENT IN A LARGE, UNSELECTED STUDY COHORT. 4,374 LIVER ABLATIVE PROCEDURES FOR BOTH PRIMARY AND SECONDARY LIVER MALIGNANCIES CONDUCTED BETWEEN 2005 AND 2020 WERE INCLUDED IN THE STUDY. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED TO REMOVE A COAXIAL NEEDLE PREVIOUSLY USED TO PUNCTURE THE INTRAHEPATIC LESION THE PATIENT WAS BEING TREATED FOR. THE MOST FREQUENTLY OBSERVED COMPLICATIONS INCLUDED BLOOD TRANSFUSIONS, EXTENDED VENTILATION EXCEEDING 48 HOURS, SEPSIS, PERITONITIS, AND PNEUMONIA. WITHIN THE STUDY COHORT, PULMONARY EMBOLISM, ACUTE RENAL FAILURE, GASTROINTESTINAL BLEEDING, AND PNEUMONIA WERE THE PREDOMINANT COMPLICATIONS ENCOUNTERED DURING HOSPITALIZATION. THE LENGTH OF STAY (LOS) WAS NOTABLY EXTENDED IN CASES WHERE PERITONITIS, PNEUMONIA, SEPSIS, ACUTE RENAL FAILURE, AND PULMONARY EMBOLISM. OVERALL, THERE WERE ONLY A LIMITED NUMBER OF RECORDED INSTANCES OF IN-HOSPITAL MORTALITY, TOTALING 9 OUT OF 4,374 CASES. THESE FATALITIES WERE LINKED TO PRIOR PARTIAL LIVER RESECTION, COAGULOPATHY, AND ACUTE RENAL FAILURE. PRIOR PARTIAL LIVER RESECTION WAS RECOGNIZED AS AN INDEPENDENT RISK FACTOR FOR COMPLICATIONS AND WAS ASSOCIATED WITH IN-HOSPITAL MORTALITY. SEVERE COMPLICATIONS AND IN-HOSPITAL DEATHS WERE REPORTED SIGNIFICANTLY MORE FREQUENTLY FOLLOWING TACE TREATMENT COMPARED TO ALL OTHER TREATMENT MODALITIES. THE INCREASED OCCURRENCE OF COMPLICATIONS AND IN-HOSPITAL MORTALITY AFTER TACE TREATMENT MAY BE ASSOCIATED WITH PRE-EXISTING LIVER CIRRHOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE BRACHYTHERAPY JOURNAL. THE STUDY WAS AIMED TO INVESTIGATE COMPLICATIONS AND MORTALITY AFTER ABLATIVE TREATMENT IN A LARGE, UNSELECTED STUDY COHORT. 4,374 LIVER ABLATIVE PROCEDURES FOR BOTH PRIMARY AND SECONDARY LIVER MALIGNANCIES CONDUCTED BETWEEN 2005 AND 2020 WERE INCLUDED IN THE STUDY. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED AFTER AN 18 G COAXIAL NEEDLE WAS USED TO PUNCTURE THE INTRAHEPATIC LESION, FOLLOWED BY THE REMOVAL OF THE NEEDLE AND THE INSERTION OF A NON-BOSTON SCIENTIFIC (BSC) 6F ANGIOGRAPHIC CATHETER SHEATH. FINALLY, A 6 F NON-BSC IRRADIATION CATHETER WAS PLACED WITHIN THE CATHETER SHEATH. IN LARGER OR IRREGULAR-SHAPED LESIONS, MULTIPLE CATHETERS WERE INSERTED. AFTER INSERTION, THE IMAGING DATA (AXIAL SLICES WITH 3 MM THICKNESS) WERE TRANSFERRED TO THE NON-BSC IRRADIATION PLANNING SYSTEM FOR HIGH-DOSE-RATE BRACHYTHERAPY (HDR-BT). THE MOST FREQUENTLY OBSERVED COMPLICATIONS INCLUDED BLOOD TRANSFUSIONS, EXTENDED VENTILATION EXCEEDING 48 HOURS, SEPSIS, PERITONITIS, AND PNEUMONIA. WITHIN THE STUDY COHORT, PULMONARY EMBOLISM, ACUTE RENAL FAILURE, GASTROINTESTINAL BLEEDING, AND PNEUMONIA WERE THE PREDOMINANT COMPLICATIONS ENCOUNTERED DURING HOSPITALIZATION. THE LENGTH OF STAY (LOS) WAS NOTABLY EXTENDED IN CASES WHERE PERITONITIS, PNEUMONIA, SEPSIS, ACUTE RENAL FAILURE, AND PULMONARY EMBOLISM. OVERALL, THERE WERE ONLY A LIMITED NUMBER OF RECORDED INSTANCES OF IN-HOSPITAL MORTALITY, TOTALING 9 OUT OF 4,374 CASES. THESE FATALITIES WERE LINKED TO PRIOR PARTIAL LIVER RESECTION, COAGULOPATHY, AND ACUTE RENAL FAILURE. PRIOR PARTIAL LIVER RESECTION WAS RECOGNIZED AS AN INDEPENDENT RISK FACTOR FOR COMPLICATIONS AND WAS ASSOCIATED WITH IN-HOSPITAL MORTALITY. SEVERE COMPLICATIONS AND IN-HOSPITAL DEATHS WERE REPORTED SIGNIFICANTLY MORE FREQUENTLY FOLLOWING TACE TREATMENT COMPARED TO ALL OTHER TREATMENT MODALITIES. THE INCREASED OCCURRENCE OF COMPLICATIONS AND IN-HOSPITAL MORTALITY AFTER TACE TREATMENT MAY BE ASSOCIATED WITH PRE-EXISTING LIVER CIRRHOSIS. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS REPORT WAS SUBMITTED IN ERROR. THERE ARE NO ADVERSE EVENTS ATTRIBUTABLE TO THE AMPLATZ SUPER STIFF GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640268 AMPLATZ SUPER STIFF WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death