BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX 1.5MM X 149CM 4F ATHERECTOMY SYSTEM

    MDR report key: 21727069 · Received March 28, 2025

    Report

    Report Number
    3007284006-2025-00057
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 31, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    UDI-DI
    00845225003173
    PMA / PMN Number
    K211518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2 (DOB)-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 E1 & G2: COUNTRY IS AUSTRALIA. BLOCKS H3 & H6: THE PHOENIX CATHETER WAS NOT RETURNED TO THE MANUFACTURER 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.

    Additional Manufacturer Narrative · 0

    BLOCKS A2 & A3: PATIENT INFORMATION AVAILABLE. BLOCK B: UPDATED TO CAPTURE NEW INFORMATION RECEIVED. BLOCK E4: UPDATED FROM UNK TO NO. BLOCK H6: IT WAS CONFIRMED THAT THE DEVICE WAS DISCARDED AND THAT THE 1.5 MM PHOENIX CATHETER WAS USED IN A 1.2 MM VESSEL. THE IFU WARNS: DO NOT OPERATE THE PHOENIX ATHERECTOMY SYSTEM IN VESSELS SMALLER THAN THE INDICATED SIZE AS PERFORATIONS, DISSECTIONS OR INJURY MAY OCCUR. -UPDATED TYPE OF INVESTIGATION B17 (DEVICE NOT RETURNED) TO B18 (DEVICE DISCARDED) -UPDATED INVESTIGATION FINDINGS: C20 (NO FINDINGS AVAILABLE) TO C23 (USAGE PROBLEM IDENTIFIED) -UPDATED INVESTIGATION CONCLUSIONS D14 (NO PROBLEM DETECTED) TO D1101 (FAILURE TO FOLLOW INSTRUCTIONS), ADDED D12 (KNOWN INHERENT RISK OF DEVICE) ALL OTHER CODES IN THE INITIAL MDR REMAIN APPLICABLE. 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 (1.5 MM) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, ANGIOGRAPHIC RUN SHOWED EXTRAVASATION OF CONTRAST, BUT IT IS UNKNOWN HOW THE PERFORATION WAS TREATED. FURTHER INFORMATION STATES THAT THE VESSEL MAY HAVE BEEN UNDERSIZED FOR THE SELECTED 1.5 MM PHOENIX CATHETER. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A PERFORATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE PHOENIX CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PHOENIX CATHETER (1.5 MM) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, ANGIOGRAPHIC RUN SHOWED EXTRAVASATION OF CONTRAST IN THE PERONEAL ARTERY, REQUIRING A BALLOON TO TREAT THE PERFORATION. FURTHER INFORMATION STATES THE TARGET VESSEL WAS THOUGHT TO BE 1.9 MM; HOWEVER, IT WAS CONFIRMED TO BE SMALLER AT 1.2 MM. PER PHILIPS CLINICAL ASSESSMENT, THE USE OF AN OVERSIZED CATHETER LIKELY CONTRIBUTED TO THE PERFORATION. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A PERFORATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE PHOENIX CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692793 PHOENIX 1.5MM X 149CM 4F ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION P15149K 11302327 00845225003173

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female UNK MFG AND SIZE: INTRODUCER SHEATH.| VOLCANO: 0.014 PHOENIX GUIDEWIRE.