BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT VERSATURN GUIDE WIRE

    MDR report key: 6125073 · Received November 23, 2016

    Report

    Report Number
    2024168-2016-08313
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 14, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: DILATATION CATHETER: PANTERA REO 3.0X12, GUIDE CATHETER: RADIGUIDE, STENT: XIENCE ALPINE 3.0 X 28 MM. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND DIMENSIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE DIFFICULTY REMOVING THE GUIDE WIRE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. POST-DILATATION WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS PERFORMED AFTER A XIENCE ALPINE DRUG ELUTING STENT (DES) WAS IMPLANTED AT THE LESION SITE. WHEN THE VERSATURN GUIDE WIRE (GW) WAS RETRACTED DURING REMOVAL, RESISTANCE WAS FELT BETWEEN THE GW AND THE STENT IMPLANT. THE GW WAS REMOVED UNDER TORQUE WITHOUT BEING DAMAGED. IT WAS STATED THAT THE METHOD APPLIED IN SHAPING THE GW TIP WITH THE INSERTION TOOL MAY HAVE COMPROMISED THE TIP. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776978 HT VERSATURN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 6081761

    Patients

    Seq Age Sex Outcome Treatment
    1