BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 25084511 · Received May 5, 2026

    Report

    Report Number
    9681477-2026-00056
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 5, 2026
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED FOR ANALYSIS. THE END USER DID NOT PROVIDE LOT TRACEABILITY; THEREFORE, LAKE REGION MEDICAL WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING, AND PACKAGING OF THIS PRODUCT. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "PHYSICIAN PREFERENCE" APPEARS TO HAVE IMPACTED ON THE EVENT AS REPORTED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL HAS NO OPEN PREVENTATIVE ACTION SPECIFIC TO MANUFACTURING THIS PRODUCT DIFFERENTLY. AS INDICATED IN THE IFU (INSTRUCTIONS FOR USE) PRECAUTIONS SECTION: NEVER ADVANCE THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE REASON FOR RESISTANCE UNDER FLUOROSCOPY.

    Description of Event or Problem · 0

    DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED, PROCEDURE COMPLETED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. EVENT DESCRIPTION: ECN EVENT DESCRIPTION: WIRE CONTINUED TO BE DIFFUSE TO ADVANCE AND RETRACT FROM FARA WAVE WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? SAME AS ABOVE WHAT IS THE NEXT COURSE OF ACTION? CONTINUED WITH THE SAME CATHETER. PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: UNKNOWN PROCEDURE NUMBER: PN-3121641 EVENT DATE: 2026-4-8. AS REPORTED DEVICE CODES: 1457: ENTRAPMENT OF DEVICE OR DEVICE COMPONENT. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361699 STARTER GUIDEWIRE STARTER GUIDEWIRE DQX LAKE REGION MEDICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown