BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-ELITE LASER ATHERECTOMY CATHETER

    MDR report key: 24313137 · Received February 11, 2026

    Report

    Report Number
    3007284006-2026-00022
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 22, 2021
    Report Date
    December 14, 2023
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K250385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2-A6) PATIENT INFORMATION - GENERALIZED PATIENT INFORMATION WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. B3) ARTICLE CITATION: BÜRCKENMEYER F, ASCHENBACH R, DIAMANTIS I, TEICHGRÄBER U. EXCIMER LASER ATHERECTOMY IN COMPLEX PERIPHERAL ARTERY DISEASE: A PROSPECTIVE EUROPEAN REGISTRY. J CARDIOVASC SURG (TORINO). 2021 APR;62(2):153-161. EPUB 2021 JAN 22. PMID: 33480520. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B5/D1) DUE TO LIMITED INFORMATION AVAILABLE, IT IS UNKNOWN WHICH DEVICE (TURBO ELITE OR TURBO TANDEM) CONTRIBUTED TO THE KNOWN INJURIES; THEREFORE, AN MDR WAS SUBMITTED FOR EACH DEVICE MENTIONED. B6/B7) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY - GENERALIZED PATIENT INFORMATION WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. D4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM GERMANY, PHYSICIAN AND FACILITY INFORMATION ARE UNKNOWN; THEREFORE, THE INFORMATION LISTED IS THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE. H3) THE DEVICE WAS DISCARDED; THUS, NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, PERFORATION, ARTERIOVENOUS FISTULA, EMBOLISM, AMPUTATION, RESIDUAL STENOSIS, THROMBOSIS, AND DISSECTION ARE LISTED AS POTENTIAL ADVERSE EVENTS WITH USE OF TURBO-ELITE 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.

    Additional Manufacturer Narrative · 0

    PER FDA REQUEST: SECTION B5: INCLUDE ARTICLE CITATION. SECTION H11: THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW FOR LITERATURE MDR PER CAPA 207.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE (PUBLISHED ONLINE 22JAN2021) TITLED "EXCIMER LASER ATHERECTOMY IN COMPLEX PERIPHERAL ARTERY DISEASE: A PROSPECTIVE EUROPEAN REGISTRY". THE ARTICLE RETROSPECTIVELY REVIEWED DATA OF PATIENTS WHO UNDERWENT EXCIMER LASER ATHERECTOMY (ELA) FOR THE TREATMENT OF COMPLEX LOWER LIMB ARTERY DISEASE. A TOTAL OF 294 PATIENTS ENROLLED AT 14 EUROPEAN CENTERS. THE ELA PROCEDURES WERE PERFORMED USING SPECTRANETICS CVX-300 EXCIMER LASER SYSTEMS, SPECTRANETICS TURBO-ELITE, AND TURBO-TANDEM LASER ATHERECTOMY CATHETERS. PERIPROCEDURAL COMPLICATIONS INCLUDED 1 PROCEDURE WHERE THE EXCIMER LASER COULD NOT BE RESTARTED AFTER INTERRUPTION DUE TO SYSTEM ERROR (MDR # 3007284006-2026-00019). IN 2 PATIENTS, LASER ATHERECTOMY RESULTED IN PERFORATION THAT WAS RESOLVED BY COVERED STENTS. BAILOUT STENTING WAS ALSO REQUIRED IN 38 DISSECTIONS, 42 PATIENTS WITH RESIDUAL STENOSIS, AND 3 PATIENTS WITH THROMBOSIS. IN 1 PATIENT, AN ARTERIO-VENOUS FISTULA WAS SUCCESSFULLY TREATED WITH POBA. TWO (2) CASES OF DISTAL EMBOLISM WERE TREATED WITH ASPIRATION OR LOCAL LYSIS. FOUR (4) PATIENTS UNDERWENT MINOR OR MAJOR AMPUTATION AT ONE, SIX, AND NINE MONTHS FOLLOW-UP. (MDR #3007284006-2026-00022, MDR #3007284006-2026-00023). ONE (1) PATIENT DIED 2 MONTHS AFTER LASER ATHERECTOMY AND 1 MONTH AFTER MINOR AMPUTATION OF THE FOOT. INITIAL CAUSE OF DEATH IS UNKNOWN (MDR #3007284006-2026-00020, MDR #3007284006-2026-00021). ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR EACH OF THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 22JAN2021 HAS BEEN USED, THE DATE OF PUBLICATION. THIS REPORT CAPTURES THE 2 PERFORATIONS, 1 ARTERIOVENOUS FISTULA, 2 DISTAL EMBOLISMS, 4 AMPUTATIONS, 42 RESIDUAL STENOSIS, 3 THROMBOSIS, AND 38 DISSECTIONS THAT OCCURRED WITH USE OF THE TURBO-ELITE DEVICES. THERE WAS NO ALLEGED MALFUNCTION OF THE TURBO-ELITE DEVICES IN USE DURING THE PROCEDURE.

    Description of Event or Problem · 0

    ARTICLE CITATION: BÜRCKENMEYER F, ASCHENBACH R, DIAMANTIS I, TEICHGRÄBER U. EXCIMER LASER ATHERECTOMY IN COMPLEX PERIPHERAL ARTERY DISEASE: A PROSPECTIVE EUROPEAN REGISTRY. J CARDIOVASC SURG (TORINO). 2021 APR;62(2):153-161. EPUB 2021 JAN 22. PMID: 33480520.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56904 TURBO-ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.