BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX GUIDEWIRE

    MDR report key: 25029703 · Received April 29, 2026

    Report

    Report Number
    9681477-2026-00052
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 29, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING THE RETURN OF THE DEVICE. 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.

    Description of Event or Problem · 0

    WE HAVE RECEIVED A COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 8545624 WHERE THERE MAY HAVE BEEN A SMALL OF THE WIRE DETACHED. THE DEVICE WILL BE RETURNED FOR EVALUATION. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4). DATE OF EVENT: (B)(6) 2026. PHILIPS REPORTABILITY AWARE DATE: 4/02/2026.. COUNTRY: GERMANY (DEU). NATURE OF COMPLAINT: THE PROBLEM WAS THAT THE PHOENIX HAD GNAWED ITS WAY INTO THE WIRE IN THE POPLITEAL REGION. THE WIRE WAS FIXED AT THE WIRE CLIP, AND THEY USED THE DEVICE AS INTENDED. THE COMPLAINT HAPPENED TODAY MORNING DURING A CTO OCCLUSION IN THE POPLITEAL AREA IN THE LEG. A LITTLE PIECE OF THE WIRE WAS MAYBE LOST IN THE PATIENT, BUT THEY COULD TREAT THE PATIENT WITH A DCB AFTERWARDS. IN GENERAL, THE PHOENIX COULD SOLVE THE PROBLEM OF THE CTO AND GAINED NEW LUMEN IN THE VESSEL. ADDITIONAL INFORMATION WAS RECEIVED ON 04/07/2026. THE NATURE OF THE COMPLAINT HAS BEEN UPDATED. THE SOURCE DOCUMENT IS ATTACHED. THIS IS AN ARTERIAL OCCLUSION IN THE POPLITEAL REGION. THE PHOENIX 1.8 WAS ADVANCED VIA THE PHOENIX GUIDEWIRE TO THE SITE OF THE OCCLUSION. THE PHOENIX PERFORMED VERY WELL AND FULLY REOPENED THE VESSEL. AT THE DISTAL END OF THE OCCLUSION, HOWEVER, THE PHOENIX WIRE ROTATED DESPITE BEING SECURED TO THE TORKER, AND THE PHOENIX DRILL HEAD BORED INTO THE WIRE. THE DEVICE SUBSEQUENTLY BECAME JAMMED AND WAS REMOVED FROM THE ARTERY. UNFORTUNATELY, THE GUIDEWIRE DETACHED AT THE FRONT, AND THE TWO TREATING DOCTORS DISCOVERED (PERHAPS) A SMALL PIECE OF THE WIRE DURING AN ANGIOGRAM OF THE LOWER LEG BUT WERE UNABLE TO CONFIRM THIS WITH 100% CERTAINTY. FOLLOWING REMOVAL OF THE PHOENIX DEVICE, THE PATIENT WAS TREATED WITH A DCB AND WAS STABLE AND IN GOOD SPIRITS AFTER THE PROCEDURE. TYPE OF CASE: PERIPHERAL. ACCESS LOCATION: UNKNOWN. VESSEL TORTUOSITY: MODERATE. PROCEDURE TYPE: THERAPEUTIC. WAS RESISTANCE ENCOUNTERED?: YES. LESION CALCIFICATION: SEVERE. TYPE OF "TARGET" LESION: CTO . PERIPHERAL VESSEL: POP. VESSEL SEGMENT: DISTAL. ACCESS APPROACH: UNKNOWN. CHRONIC TOTAL OCCLUSION (CTO)? YES. DID AN EMBOLIZATION OCCUR? NO. WAS THE SUPPORT CLIP USED? (PHOENIX CATHETER): YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088526 PHOENIX GUIDEWIRE GUIDEWIRE, PRODUCT CODE: DQX DQX LAKE REGION MEDICAL LIMITED OFG2524LF 8545624 10845225002760

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Required Intervention