BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 3131838 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03319
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE 1.2 X 12 MM ARMADA 14 XT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A NARROW AND ECCENTRIC LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY. DURING ADVANCEMENT OF THE 1.2 X 12 MM ARMADA BALLOON CATHETER AND THE WINN GUIDE WIRE, THE PHYSICIAN STATED THAT HE WAS UNABLE TO ADVANCE THE DEVICES TO THE ANTERIOR TIBIAL ARTERY. DURING ADVANCEMENT, THERE WAS NO RESISTANCE WITH THE GUIDE WIRE, BUT WHEN THE ARMADA BALLOON WAS ATTEMPTED TO BE REMOVED, IT WAS FOUND TO BE STUCK ON THE WINN GUIDE WIRE; THEREFORE, THE DEVICES WERE REMOVED TOGETHER. A NEW BALLOON CATHETER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. 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
    235061 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2121171

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: 1.2 X 12 MM ARMADA 14