BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX GUIDEWIRE

    MDR report key: 25256328 · Received May 22, 2026

    Report

    Report Number
    9681477-2026-00061
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 22, 2026
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    UDI-DI
    10845225002760
    PMA / PMN Number
    K080144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AWAITING RETURN DEVICE.

    Description of Event or Problem · 0

    WE HAVE RECEIVED A COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 7932009 WHERE PARTS OF THE GUIDE DETACHED AND REMAIN IN THE PATIENT. WE ARE INQUIRING ABOUT THE DEVICE RETURN. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. NATURE OF COMPLAINT: WRITTEN FROM CUSTOMER : USED DEVICE, PHILIPS PHOENIX ARTEHERCTOMY SYSTEM. REF: (B)(4), WHERE THE GUIDEWIRES SUBSEQUENTLY SPLIT / FRAY INSIDE THE BLOOD VESSEL. PARTS OF THE GUIDE DETACH AND REMAIN IN THE PATIENT. TYPE OF CASE: PERIPHERAL. ACCESS LOCATION: UNKNOWN. VESSEL TORTUOSITY: UNKNOWN. PROCEDURE TYPE: UNKNOWN. WAS RESISTANCE ENCOUNTERED?: UNKNOWN. LESION CALCIFICATION: UNKNOWN. TYPE OF "TARGET" LESION: UNKNOWN. PERIPHERAL VESSEL: UNKNOWN. VESSEL SEGMENT: UNKNOWN. ACCESS APPROACH: UNKNOWN. CHRONIC TOTAL OCCLUSION (CTO)? UNKNOWN. DID AN EMBOLIZATION OCCUR? NO. WAS THE SUPPORT CLIP USED? (PHOENIX CATHETER): UNKNOWN. COMPLAINT # (B)(4). DATE OF EVENT: 4/29/2026. PHILIPS REPORTABILITY AWARE DATE: 4/29/2026. COUNTRY: DENMARK (DNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485366 PHOENIX GUIDEWIRE GUIDEWIRE, PRODUCT CODE: DQX, PRODUCT CODE: DQX, PRODUCT CODE: DQX DQX LAKE REGION MEDICAL LIMITED OFG2524LF 7932009 10845225002760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other