BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX 2.4MM X 130CM 7F PRE-DEFLECTING ATHERECTOMY SYSTEM

    MDR report key: 21706870 · Received March 27, 2025

    Report

    Report Number
    3007284006-2025-00053
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 12, 2025
    Report Date
    March 27, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    UDI-DI
    00845225003197
    PMA / PMN Number
    K211518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, A4, A5: DATE OF BIRTH, WEIGHT, AND ETHNICITY- 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 GERMANY. BLOCKS H3 & H6: THE PHOENIX CATHETER WAS NOT RETURNED FOR EVALUATION, THUS NO RETURNED 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 ATHERECTOMY CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. THE PHOENIX CATHETER WAS DELIVERED OVER A 0.014" PHOENIX GUIDEWIRE WITH NO ISSUES. HOWEVER, DURING REMOVAL, THE CATHETER GOT STUCK ON THE GUIDEWIRE, AND BOTH WERE REMOVED AS A SYSTEM. VISIBLE UNDER FLUOROSCOPY, THE TIP OF THE GUIDEWIRE (MDR 9681477-2025-00026) HAD SEPARATED AND WAS STENTED TO THE VESSEL WALL. SINCE THE ATHERECTOMY PROCEDURE WAS NOT SUFFICIENT AS EXPECTED DUE TO THE SEVERELY CALCIFIED LESION, THE PATIENT WAS BROUGHT BACK FIVE DAYS LATER FOR BYPASS. 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
    1602945 PHOENIX 2.4MM X 130CM 7F PRE-DEFLECTING ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION PD24130K 02202401 00845225003197

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male TERUMO: 7F CROSS OVER INTRODUCER SHEATH.| VOLCANO: 0.014 PHOENIX GUIDEWIRE.