BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX 2.2MM X 149CM 6F ATHERECTOMY SYSTEM

    MDR report key: 20991878 · Received December 20, 2024

    Report

    Report Number
    3007284006-2024-00248
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 20, 2024
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    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. A6: PATIENT RACE NOT PROVIDED. C: NOT APPLICABLE FOR THIS DEVICE. D4: SERIAL # NOT APPLICABLE FOR THIS DEVICE. D6 AND D7: NOT APPLICABLE FOR THIS DEVICE. H3 AND H6: THE PHOENIX CATHETER WAS DISCARDED, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. H7, H9 AND 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 IN THE SFA. DURING REMOVAL, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND REMOVED TOGETHER. A SEPARATE GUIDEWIRE WAS USED TO REGAIN ACCESS TO THE LESION WITH 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
    2376736 PHOENIX 2.2MM X 149CM 6F ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION P22149K 3290390300

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male ABBOTT: VIPER GUIDE WIRE, SIZE UNK| TERUMO: 6F, DESTINATION INTRODUCER SHEATH