BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-ELITE LASER ATHERECTOMY CATHETER

    MDR report key: 24569588 · Received March 11, 2026

    Report

    Report Number
    3007284006-2026-00069
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    April 24, 2024
    Report Date
    February 1, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K250385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT DATE OF BIRTH - NOT AVAILABLE FROM FACILITY. A3B) PATIENT GENDER - NOT AVAILABLE FROM FACILITY. A4) PATIENT WEIGHT - NOT AVAILABLE FROM FACILITY. A5/A6) PATIENT ETHNICITY AND RACE - NOT AVAILABLE FROM FACILITY. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B6) RELEVANT TEST/LABORATORY DATA - NOT AVAILABLE FROM FACILITY. 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 FRANCE, 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, AMPUTATION IS LISTED AS A POTENTIAL ADVERSE EVENT 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.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE (PUBLISHED ONLINE 24APR2024) ¿DUCASE E ET AL_2024_OUTCOMES AND COMPARATIVE ANALYSIS OF THE INITIAL RESULT OF STANDARD BALLOON ANGIOPLASTY VERSUS DRUG-COATED BALLONS ALONE VERSUS IN ASSOCIATION WITH LASER-EXCIMER ATHERECTOMY IN THE TREATMENT OF FEMOROPOPLITEAL ARTERY IN-STENT RESTENOSIS (INTACT).¿. THE ARTICLE RETROSPECTIVELY REVIEWED A STUDY/RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE DRUG-COATED BALLOONS (DCBS) USED ALONE OR IN ASSOCIATION WITH EXCIMER LASER ATHERECTOMY (ELA) TO SIMPLE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF FEMOROPOPLITEAL- IN-STENT RESTENOSIS (ISR). A TOTAL OF 134 PATIENTS ACROSS 14 FRENCH CENTER FROM DECEMBER 2015 TO NOVEMBER 2019 WERE ENROLLED IN THE STUDY. ALL LESIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS TURBO-ELITE AND TURBO-TANDEM LASER ATHERECTOMY CATHETERS, BD BARD LUTONIX, MEDTRONIC INPACT, AND PHILIPS STELLAREX DRUG-COATED BALLOONS (DCBS), OR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). PATIENTS UNDERWENT CLINICAL FOLLOW-UP AT DISCHARGE AND CLINICAL FOLLOW-UP WITH DUPLEX ULTRASOUND (DUS) AT 1, 6, 12, AND 18 MONTHS. DEATHS OCCURRED IN 11 PATIENTS (DUE TO SEPTIC SHOCK, PNEUMONIA, CANCER, SLIP SYNDROME, MYOCARDIAL INFARCTION, PNEUMONIA, OR STROKE (MDR #3007284006-2026-00070, MDR #3007284006-2026-00071, MDR #3016257349-2026-00006). ADDITIONALLY POST-PROCEDURE COMPLICATIONS INCLUDED 6 AMPUTATIONS (65-YEAR-OLD (MDR #3007284006-2026-00068) AND 76-YEAR-OLD MALE (MDR #3007284006-2026-00069) DUE TO RESTENOSIS AFTER USE OF THE TURBO-ELITE), 31 OCCLUSIONS, 25 PATIENTS REQUIRED ADDITIONAL STENTING, AND 8 REQUIRED BYPASS PROCEDURE (MDR #3007284006-2026-00072, MDR #3007284006-2026-00073, MDR #3016257349-2026-00007). ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR MOST OF THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 24APR2024 HAS BEEN USED, THE DATE OF PUBLICATION. ARTICLE CITATION: DUCASE E ET AL_2024_OUTCOMES AND COMPARATIVE ANALYSIS OF THE INITIAL RESULT OF STANDARD BALLOON ANGIOPLASTY VERSUS DRUG-COATED BALLONS ALONE VERSUS IN ASSOCIATION WITH LASER-EXCIMER ATHERECTOMY IN THE TREATMENT OF FEMOROPOPLITEAL ARTERY IN-STENT RESTENOSIS (INTACT). JOURNAL OF ENDOVASCULAR THERAPY 1¿15. J ENDOVASC THER 2026 FEB;33(1):244-258. EPUB 2024 APR 24. ARTICLE LINK: DOI: 10.1177/15266028241248333HTTPS://DOI.ORG/10.1177/1526602824124833 THIS REPORT CAPTURES THE 76-YEAR-OLD MALE THAT UNDERWENT AMPUTATION AFTER USE WITH A TURBO-ELITE DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS/PHILIPS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627487 TURBO-ELITE LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male GUIDEWIRE (MANUFACTURER, SIZE UNK)| INTRODUCER SHEATH (MANUFACTURER, SIZE UNK)| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM