BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX GUIDEWIRE

    MDR report key: 10572383 · Received September 23, 2020

    Report

    Report Number
    9681477-2020-00013
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 10, 2020
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    UDI-DI
    10845225002760
    PMA / PMN Number
    K080144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT AVAILABLE FOR RETURN, APPROPRIATE CODES COMPLETED.

    Description of Event or Problem · 0

    THE PHOENIX WIRE WAS LOCK TO THE PHOENIX CATHETER AT THE END OF FINAL RUN. THE WIRE AND THE CATHETER WAS REMOVED WITH NO ISSUES. THE REST OF THE PROCEDURE WAS COMPLETED WITH BALLOON. ASSOCIATED WITH PHOENIX CATHETER (PHOENIX CATHETER SYSTEM, 1.8MM) COMPLAINT (B)(4). NO PATIENT INJURY. DATE OF OCCURRENCE: (B)(6) 2020. DATE OF AWARENESS: 8/27/2020. AS PER COMPLAINT FILE - DAN LANG RESPONDED: -PLEASE CONFIRM IF THERE WAS A PHOENIX WIRE FAILURE AS WELL? THE WAY I WAS TOLD, IT WAS A WIRE LOCK DUE TO COATING FAILURE. -PLEASE EXPLAIN HOW DID THE DEVICE FAIL? THE WAY I WAS TOLD, IT WAS A WIRE LOCK DUE TO COATING FAILURE.

    Additional Manufacturer Narrative · 1

    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. DEVICE IS EXPECTED TO RETURN FOR EVALUATION.

    Description of Event or Problem · 1

    THE PHOENIX WIRE WAS LOCK TO THE PHOENIX CATHETER AT THE END OF FINAL RUN. THE WIRE, AND THE CATHETER WAS REMOVED WITH NO ISSUES. THE REST OF THE PROCEDURE WAS COMPLETED WITH BALLOON. ASSOCIATED WITH PHOENIX CATHETER (PHOENIX CATHETER SYSTEM, 1.8MM) COMPLAINT (B)(4). NO PATIENT INJURY. DATE OF OCCURRENCE: (B)(6) 2020. DATE OF AWARENESS: 8/27/2020. AS PER COMPLAINT FILE, (B)(6) RESPONDED: PLEASE CONFIRM IF THERE WAS A PHOENIX WIRE FAILURE AS WELL? THE WAY I WAS TOLD, IT WAS A WIRE LOCK DUE TO COATING FAILURE. PLEASE EXPLAIN HOW DID THE DEVICE FAIL? THE WAY I WAS TOLD, IT WAS A WIRE LOCK DUE TO COATING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040677 PHOENIX GUIDEWIRE GUIDEWIRE DQX LAKE REGION MEDICAL LIMITED PG14300LF 10950858 10845225002760

    Patients

    Seq Age Sex Outcome Treatment
    1 PHOENIX CATHETER SYSTEM, 1.8MM| PHOENIX CATHETER SYSTEM, 1.8MM| PHOENIX CATHETER SYSTEM, 1.8MM