BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX 1.5MM X 149CM 4F ATHERECTOMY SYSTEM

    MDR report key: 24655562 · Received March 20, 2026

    Report

    Report Number
    3007284006-2026-00089
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 20, 2026
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K211518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2-A6: NOT AVAILABLE FROM FACILITY. BLOCKS B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCK D4: SERIAL # NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D1 & G: ADDRESS LISTED REFLECTS THE SPECIFICATION DEVELOPER. BLOCKS E1 & G2: COUNTRY IS AUSTRALIA. BLOCKS H3 & H6: THE PHOENIX CATHETER WAS NOT RETURNED FOR EVALUATION; THUS, NO PRODUCT INVESTIGATION WAS PERFORMED. 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 PERIPHERAL PROCEDURE. DURING USE, FRICTION BUILT UP ON THE PHOENIX CATHETER AND BECAME STUCK ON THE NON-PHILIPS GUIDEWIRE; THEREFORE, REMOVED TOGETHER. A PHOENIX CATHETER AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER AND 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
    710473 PHOENIX 1.5MM X 149CM 4F ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION P15149K 10182317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT: 0.014 IRONMAN GUIDEWIRE.| TERUMO: 6F INTRODUCER SHEATH.