BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX 1.8MM X 149CM 5F ATHERECTOMY CATHETER

    MDR report key: 24318203 · Received February 11, 2026

    Report

    Report Number
    3007284006-2026-00047
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 6, 2026
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K143328
    Adverse Event
    Yes
    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. BLOCKS A2 & A4: DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FROM FACILITY. BLOCKS B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D4 & H4: THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. SERIAL # NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PHOENIX CATHETER WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. BLOCKS H7 & H9: 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.

    Additional Manufacturer Narrative · 0

    BLOCK H3: THE PHOENIX CATHETER WAS RETURNED INTACT WITH A PHOENIX GUIDEWIRE, ALONG WITH A STENT STUCK TO THE GUIDEWIRE, WHICH ALIGNS WITH THE REPORTED COMPLAINT (CATHETER ONLY REMOVED WITH GUIDEWIRE TO NOT LOSE STENT). VISUAL INSPECTION OF BOTH THE CATHETER AND GUIDEWIRE FOUND NO UNUSUAL CHARACTERISTICS OF THE DEVICE. DURING FUNCTIONAL TESTING, THE CATHETER WAS ABLE TO BE REMOVED FROM THE GUIDEWIRE WITH NO ISSUES. ADDITIONALLY, THE CATHETER GEAR WOULD NOT ROTATE FREELY, AS IT RETURNED BACK TO ITS ORIGINAL POSITION. BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE IS LIKELY DUE TO USE ERROR. THE IFU SATES THAT THE SAFETY AND EFFECTIVENESS OF THE PHOENIX ATHERECTOMY SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH IN-STENT RESTENOSIS AT THE PERIPHERAL VASCULAR SITE. 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 FOR A PERIPHERAL PROCEDURE IN THE PROXIMAL TP TRUNK. DURING USE, THE CATHETER GRABBED AN EXISTING STENT STRUT AND WAS REMOVED ALONG WITH THE 0.014" PHOENIX GUIDEWIRE IN ORDER TO NOT LOSE THE STENT IN THE BODY. A NEW STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM, REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238840 PHOENIX 1.8MM X 149CM 5F ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION P18149

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female CORDIS: 6F, INTRODUCER SHEATH| PHILIPS: PHOENIX EXTRA SUPPORT GUIDEWIRE