BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 3950429 · Received July 22, 2014

    Report

    Report Number
    2024168-2014-04686
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 2, 2014
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STRETCHED TIP WAS CONFIRMED. ADDITIONALLY THE CORE WAS SEPARATED 1.6 CM PROXIMAL TO THE TIP SOLDER. THE COILS WERE NOT SEPARATED. THE FAILURE TO ADVANCE COULD AND DIFFICULTY REMOVING COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A OCCLUDED LESION IN THE DISTAL FEMORAL VEIN WITH HEAVY CALCIFICATION. THE WINN GUIDE WIRE WAS ADVANCED IN AN ATTEMPT TO CROSS THE DISTAL OCCLUSION, BUT RESISTANCE WAS MET WITH THE LESION. THE GUIDE WIRE WAS PULLED AND RESISTANCE WAS NOTED WITH THE LESION DURING REMOVAL. WHILE PULLING THE GUIDE WIRE, THE DISTAL TIP BECAME STRETCHED AND LENGTHENED. NO PORTION OF THE GUIDE WIRE APPEARED SEPARATED. A NEW GUIDE WIRE WAS USED. 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
    427626 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 3042471

    Patients

    Seq Age Sex Outcome Treatment
    1