BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-TANDEM LASER GUIDE CATHETER WITH LASER ATHERECTOMY CATHETER

    MDR report key: 24401008 · Received February 20, 2026

    Report

    Report Number
    3007284006-2026-00049
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    October 2, 2019
    Report Date
    November 1, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. 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/G4/H4) THE LOT NUMBER WAS NOT PROVIDED; THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, 510K NUMBER, 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, DISSECTION, EMBOLIZATION, ACUTE LIMB ISCHEMIA, BYPASS, AMPUTATION, AND MYOCARDIAL INFARCTION ARE LISTED AS POTENTIAL ADVERSE EVENTS WITH USE OF TURBO-TANDEM 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 02OCT2019) ¿TURBO-POWER LASER ATHERECTOMY COMBINED WITH DRUG-COATED BALLOON ANGIOPLASTY IS ASSOCIATED WITH IMPROVED ONE-YEAR OUTCOMES FOR THE TREATMENT OF TOSAKA II AND III FEMOROPOPLITEAL IN-STENT RESTENOSIS¿. THE ARTICLE RETROSPECTIVELY REVIEWED DATA OF PATIENTS WHO UNDERWENT A COMBINATION OF DRUG-COATED BALLOONS (DCB), PLAIN BALLOON ANGIOPLASTY (BA), AND LASER ATHERECTOMY (LA) WITH USE OF SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETERS, SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETERS, AND SPECTRANETICS TURBO-TANDEMS. THIS WAS A DUAL-CENTER RETROSPECTIVE STUDY ENROLLING 78 CONSECUTIVE PATIENTS WITH TOSAKA TYPE II (N = 18) OR III (N = 60) FEMOROPOPLITEAL IN-STENT RESTENOSIS (FP-ISR) FROM 2015 TO 2017. PERIPROCEDURAL COMPLICATIONS INCLUDED 8 DISSECTIONS OR DISTAL EMBOLIZATIONS, AND 42 REQUIRED BAIL-OUT STENTING. OUTCOMES IN FOLLOW-UP INCLUDED 4 MAJOR ADVERSE LIMB EVENTS (ACUTE LIMB ISCHEMIA, LOWER LIMB BYPASS, OR AMPUTATION) AND 1 MYOCARDIAL INFARCTION WITH USE OF THE TURBO-POWER (MDR #3007284006-2026-00048), TURBO-TANDEM (MDR #3007284006-2026-00049), AND TURBO-ELITE (MDR #3007284006-2026-00050). 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, 02OCT2019 HAS BEEN USED, THE DATE OF PUBLICATION. ARTICLE CITATION: STEFANOS GIANNOPOULOS A, DAMIANOS G. KOKKINIDIS A, OMAR JAWAID A, SEAN BEHAN A, PRIOHOSSAIN B, BEJAN ALVANDI B, T. RAYMOND FOLEY A, GAGAN D. SINGH B, STEPHEN W. WALDO A, EHRIN J. ARMSTRONG A,¿ TURBO-POWER¿ LASER ATHERECTOMY COMBINED WITH DRUG-COATED BALLOON ANGIOPLASTY IS ASSOCIATED WITH IMPROVED ONE-YEAR OUTCOMES FOR THE TREATMENT OF TOSAKA II AND III FEMOROPOPLITEAL IN-STENT RESTENOSIS. 1553-8389/© 2020 PUBLISHED BY ELSEVIER INC. RECEIVED 13 AUGUST 2019. ACCEPTED 2 OCTOBER 2019. A DIVISION OF CARDIOLOGY, ROCKY MOUNTAIN REGIONAL VA MEDICAL CENTER, UNIVERSITY OF COLORADO, DENVER, CO, USA. B DIVISION OF CARDIOVASCULAR MEDICINE, UNIVERSITY OF CALIFORNIA, DAVIS, CA, USA. * E-MAIL ADDRESS: [email protected] (E.J. ARMSTRONG). SUPPLEMENTARY DATA TO THIS ARTICLE CAN BE FOUND ONLINE AT HTTPS://DOI.ORG/10.1016/J.CARREV.2019.10.006. THIS REPORT CAPTURES THE 8 DISSECTION OR DISTAL EMBOLIZATION, 42 BAIL-OUT STENTING, 4 MAJOR ADVERSE LIMB EVENTS, AND 1 MYOCARDIAL INFARCTION WITH USE OF THE TURBO-TANDEM. 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
    461430 TURBO-TANDEM LASER GUIDE CATHETER WITH LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SPECTRANETICS/PHILIPS LASER SYSTEM.