BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX 1.8MM X 149CM 5F ATHERECTOMY SYSTEM

    MDR report key: 21305404 · Received February 4, 2025

    Report

    Report Number
    3007284006-2025-00024
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 4, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    UDI-DI
    00845225002725
    PMA / PMN Number
    K143328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCK H3: THE PHOENIX CATHETER WAS RETURNED INTACT TO A NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION OF THE CATHETER FOUND NO UNUSUAL CHARACTERISTICS OF THE DEVICE. VISUAL INSPECTION OF THE GUIDEWIRE FOUND A SLIGHTLY STRETCHED DISTAL TIP AND A KINK AT THE PROXIMAL END OF THE WIRE. DURING FUNCTIONAL TESTING, THE CATHETER WAS UNABLE TO BE SEPARATED FROM THE GUIDEWIRE. BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE (REMOVAL AS A SYSTEM) COULD NOT BE ESTABLISHED SINCE THE CATHETER COULD NOT BE REMOVED FROM THE GUIDEWIRE TO DETERMINE THE CAUSE. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. 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

    IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND BOTH WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE PHOENIX CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND A NON-PHILIPS GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159504 PHOENIX 1.8MM X 149CM 5F ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION P18149K 03072420 00845225002725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT: .014 VIPER GUIDE WIRE.| UNK MFG AND SIZE: INTRODUCER SHEATH.