BEUDAMED
    FDA Adverse Event Death Summary report: N

    TIGHTRAIL ROTATING DILATOR SHEATH

    MDR report key: 25257066 · Received May 22, 2026

    Report

    Report Number
    3007284006-2026-00254
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    May 9, 2024
    Report Date
    October 20, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRE
    PMA / PMN Number
    K150360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE - MEAN AGE 63.0 (52.0-71.0) FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND 66.0 (55.0-75.0) IN THE PACEMAKER (PM) GROUP. A3A) PATIENT SEX - 577/810 MALES AND 233/810 FEMALES IN ICD GROUP; 501/807 MALES AND 306/807 FEMALES IN PM GROUP. A3B-A6) SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B6) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY - SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. D4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM THE UNITED STATES, PHYSICIAN AND FACILITY INFORMATION ARE UNKNOWN; THEREFORE, THE INFORMATION LISTED IS THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE. G3) THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW FOR LITERATURE MDR PER CAPA 207. H3) THE DEVICE WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, DEATH IS LISTED AS A POTENTIAL ADVERSE EVENT WITH USE OF THE TIGHTRAIL DEVICES. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE (PUBLISHED ONLINE 09MAY2024) ¿COMPARISON OF OUTCOMES AND REQUIRED TOOLS BETWEEN TRANSVENOUS EXTRACTION OF PACEMAKER AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS: INSIGHT FROM SINGLE HIGH-VOLUME CENTER EXPERIENCE¿. THE STUDY RETROSPECTIVELY AIMED TO COMPARE THE SAFETY, EFFICACY, AND PROCEDURAL PROPERTIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND PACEMAKER (PM) TRANSVENOUS LEAD EXTRACTION (TLE) AND ASSESS THE IMPACT OF LEAD AGE. THE STUDY COHORT INCLUDED ALL CONSECUTIVE PATIENTS WITH ICD (N=810) AND PM (N=810) BETWEEN 2013 AND 2022. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS GLIDELIGHT LASER SHEATHS AND SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATHS. PROCEDURAL COMPLICATIONS INCLUDED 35 MAJOR COMPLICATIONS AND 7 MINOR COMPLICATIONS. IN THE ICD GROUP, 20 OF 22 CASES WITH MAJOR COMPLICATIONS WERE RELATED TO BLEEDING FROM VASCULAR OR CARDIAC CHAMBERS. THE OTHER TWO CASES WERE CAUSED BY SEPSIS OR FLASH PULMONARY EDEMA. IN THE PM GROUP, 12 OF 13 CASES WITH MAJOR COMPLICATIONS WERE RELATED TO BLEEDING FROM VASCULAR OR CARDIAC CHAMBERS. THE ONE REMAINING CASE WAS CAUSED BY LARYNGOSPASM. MINOR COMPLICATIONS WERE DEFINED AS REQUIRING MEDICAL OR MINOR PROCEDURAL INTERVENTION (MDR #3007284006-2026-00251, MDR #3007284006-2026-00252). ADDITIONALLY, THERE WAS 1 INTRAOPERATIVE DEATH, WHICH OCCURRED IN A PATIENT WITH EXTRACTION OF A 9-YEAR ICD LEAD (MDR #3007284006-2026-00253, MDR #3007284006-2026-00254). ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 09MAY2024 HAS BEEN USED, THE DATE OF PUBLICATION. HAYASHI, KATSUHIDE,CALLAHAN, THOMAS,RICKARD, JOHN,BARANOWSKI, BRYAN,MARTIN, DAVID O.,NAKHLA, SHADY,TABAJA, CHADI,PAUL, ARITRA,WILKOFF, BRUCE L. 2024. COMPARISON OF OUTCOMES AND REQUIRED TOOLS BETWEEN TRANSVENOUS EXTRACTION OF PACEMAKER AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS: INSIGHT FROM SINGLE HIGH-VOLUME CENTER EXPERIENCE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 35(7): 1382-1392. DOI:10.1111/JCE.16294. THIS REPORT CAPTURES THE DEATH THAT OCCURRED AFTER USE OF THE TIGHTRAIL DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406157 TIGHTRAIL ROTATING DILATOR SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown COOK MEDICAL EVOLUTION.| LOCKING STYLETS (MANUFACTURER UNK).| SNARES (MANUFACTURER UNK).| SPECTRANETICS GLIDELIGHT LASER SHEATH.| SPECTRANETICS/PHILIPS EXCIMER LASER SYSTEM.