BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX GUIDEWIRE

    MDR report key: 25156360 · Received May 12, 2026

    Report

    Report Number
    9681477-2026-00058
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    UDI-DI
    10845225002760
    PMA / PMN Number
    K080144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING 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 7932009; HOWEVER, THE INFORMATION REGARDING WHAT HAPPENED IS VERY LIMITED. THE CUSTOMER IS ON VACATION; THEREFORE, THE ADDITIONAL INFORMATION WILL BE PROVIDED AROUND THE 1ST WEEK OF MAY. CAN YOU PLEASE PROVIDE THE THANK YOU. COMPLAINT # (B)(4) DATE OF EVENT: 4/14/2026 PHILIPS REPORTABILITY AWARE DATE: 4/16/2026 COUNTRY: DENMARK (DNK) NATURE OF COMPLAINT: (FACILITY SOURCE DOCUMENT, GOOGLE TRANSLATE FROM DANISH TO ENGLISH): THE THIN GUIDEWIRE BROKE WHEN IT WAS REMOVED FROM THE PATIENT. WE SEND BOTH THE PHOENIX GUIDEWIRE AND PHOENIX 2.2 MM X 130 CM DEFLECTING ATHERECTOMY CATHETER (PD22130K, LOT: 02012412) / THESE TWO WERE USED TOGETHER WHEN THE GUIDEWIRE BROKE. DEVICE RETURN: UNKNOWN FOR NOW. GFES SENT, BUT STILL PENDING: 1. PLEASE PROVIDE A COMPLETED SOURCE DOCUMENT INCLUDING PAGE 5, N. REPORTABLE EVENTS. 2. PLEASE PROVIDE THE SEQUENCE OF EVENTS 3. WAS THERE AN ALLEGED MALFUNCTION WITH THE PHOENIX 2.2 MM X 130 CM DEFLECTING CATHETER? IF YES, PLEASE EXPLAIN: 4. WAS THE PHOENIX GUIDEWIRE REMOVED FROM THE BODY BY ITSELF, OR AS A UNIT TOGETHER WITH THE PHOENIX CATHETER? A) IF REMOVED TOGETHER, WAS IT BECAUSE THE DEVICES GOT STUCK/ENTANGLED? OR, B) WAS IT THE PHYSICIAN'S CHOICE TO REMOVE THEM TOGETHER? 5. WHAT OTHER DEVICES WERE BEING USED AT THE SAME TIME AS THIS DEVICE? (INCLUDE BRAND NAME AND SIZE) A. INTRODUCER SHEATH 6. WAS ANY PART OF THE DEVICE RETAINED INSIDE THE PATIENT? HOW WAS IN RETAINED IN PATIENT? (FREE FLOATING OR JAILED) 7. DID THE PHYSICIAN BELIEVE THE DEVICE CAUSED/CONTRIBUTED TO THE AE? ADDITIONAL INFORMATION: WHEN FINISHED WITH PHOENIX AND WERE GOING TO PULL THE WIRE OUT AFTERWARDS, IT FRAYED (FRAYED WIRE) PHOENIX GUIDEWIRE DOWN TO THE ANKLE (POSTERIOR). WHEN THE WIRE FRAYED THERE WAS A THIN STRAND ALL THE WAY FROM THE ANKLE UP TO THE GROIN, WHICH WAS RETRIEVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108704 PHOENIX GUIDEWIRE GUIDEWIRE, PRODUCT CODE: DQX, PRODUCT CODE: DQX DQX LAKE REGION MEDICAL LIMITED OFG2524LF 7932009 10845225002760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other