BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 3080601 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02608
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE ARMADA REFERENCED IS BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUDED, HEAVILY CALCIFIED AND ECCENTRIC DISTAL POPLITEAL ARTERY. A COMMAND GUIDE WIRE WAS ADVANCED TO THE LESION, BUT IT COULD NOT CROSS. A WINN GUIDE WIRE WAS THEN ADVANCED FURTHER THAN THE COMMAND GUIDE WIRE, BUT STILL IT COULD NOT CROSS THE LESION. THE ARMADA WAS ADVANCED AND IT ALSO COULD NOT CROSS THE LESION AND THERE WAS RESISTANCE WITH THE GUIDE WIRE WHEN REMOVING THE ARMADA, SO THE ARMADA AND WINN WIRE WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITHOUT ANY TREATMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182784 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: ARMADA