BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-POWER LASER ATHERECTOMY CATHETER

    MDR report key: 23240790 · Received October 7, 2025

    Report

    Report Number
    3007284006-2025-00207
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 10, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K222837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: HORIE K, TAKAHARA M, TAKIUCHI S, OKAMOTO S, YOSHIOKA N, KANEKO N, OGATA K, SHINTANI Y, HARAGUCHI T, IKEOKA K, KOBAYASHI T, SUZUKI K, FUKAI K, SHIMA Y, IIYA M, TADA N, IIDA O. THE ENDOVASCULAR THERAPY USING EXCIMER LASER ATHERECTOMY FOR COMPLEX FEMOROPOPLITEAL IN-STENT RESTENOSIS LESIONS. J ENDOVASC THER. 2025 AUG 20:15266028251363466. DOI: 10.1177/15266028251363466. EPUB AHEAD OF PRINT. PMID: 40832841. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY - GENERALIZED PATIENT INFORMATION WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM JAPAN, PHYSICIAN AND FACILITY INFORMATION ARE UNKNOWN; THEREFORE, THE INFORMATION LISTED IS THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE. G2) THIS EVENT WAS CAPTURED FROM INFORMATION CONTAINED WITHIN A JOURNAL ARTICLE. GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED; HOWEVER, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR EACH OF THE 46 ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. H6) EMBOLISM, PERFORATION OF VESSELS, AND RE-OCCLUSION ARE KNOWN RISKS OF COMPLICATION WITH USE OF TURBO-POWER. 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 ON 10SEP2025 OF A JOURNAL ARTICLE (PUBLISHED ONLINE 20AUG2025) TITLED "THE ENDOVASCULAR THERAPY USING EXCIMER LASER ATHERECTOMY FOR COMPLEX FEMOROPOPLITEAL IN-STENT RESTENOSIS LESIONS". THE ARTICLE RETROSPECTIVELY REVIEWED DATA OF PATIENTS WHO UNDERWENT EXCIMER LASER ATHERECTOMY (ELA) FOR IN-STENT RESTENOSIS (ISR) LESIONS IN FEMOROPOPLITEAL ARTERIES. THIS STUDY AIMED TO EVALUATE THE 1-YEAR CLINICAL OUTCOMES ENROLLING 166 PATIENTS IN A MULTICENTER REGISTRY, WHO PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD) CAUSED BY FEMOROPOPLITEAL ISR LESIONS UNDERGOING ENDOVASCULAR THERAPY (EVT) WITH ELA BETWEEN 2020 AND 2024. THE ELA PROCEDURES WERE PERFORMED USING EXCIMER LASER SYSTEMS AND SPECTRANETICS TURBO-ELITE, TURBO-POWER, AND TURBO-TANDEM LASER ATHERECTOMY CATHETERS. POST-ELA, 13 PATIENTS DEVELOPED ACUTE OCCLUSION AND 2 PATIENTS EXPERIENCED ARTERIAL PERFORATION. ADDITIONALLY, 31 PATIENTS SUFFERED FROM POST-PROCEDURAL DISTAL EMBOLIZATION. THIRTY (30) OF THE 31 PATIENTS WERE TREATED; IN WHICH 6 WERE GIVEN INFUSION OF VASODILATORS, 16 WITH CATHETER-BASED ASPIRATION, AND 8 WITH BALLOON DILATION. ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR EACH OF THE 46 ADVERSE EVENTS (13 ACUTE OCCLUSION, 2 ARTERIAL PERFORATIONS, 31 DISTAL EMBOLIZATIONS) INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE 46 EVENTS; THEREFORE, 20AUG2025 HAS BEEN USED, THE DATE OF PUBLICATION. TYPES OF DEVICES USED IN STUDY (B)(4) TOTAL): MDR # 3007284006-2025-00203- 1.7 TURBO ELITE OR MDR #3007284006-2025-00209- 1.7 TURBO TANDEM = QTY. (B)(4). MDR # 3007284006-2025-00204- 2.0 TURBO ELITE OR MDR #3007284006-2025-00210- 2.0 TURBO TANDEM = QTY. (B)(4). MDR # 3007284006-2025-00205- 2.0 TURBO-POWER = (B)(4). MDR # 3007284006-2025-00206- 2.3 TURBO ELITE = QTY. (B)(4). MDR #.- 2.3 TURBO-POWER = QTY. (B(4). MDR # 3007284006-2025-00208- 2.5 TURBO ELITE = QTY. (B)(4). THIS REPORT CAPTURES THE DISTAL EMBOLIZATIONS, ACUTE OCCLUSIONS, AND ARTERIAL PERFORATIONS DETECTED POST-ELA WITH USE OF THE SPECTRANETICS DEVICES, REQUIRING INTERVENTION. 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
    2692222 TURBO-POWER LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION 423-050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening GUIDE WIRE, MANUFACTURER/SIZE UNK| INTRODUCER SHEATH, MANUFACTURER/SIZE UNK| PHILIPS LASER SYSTEM