BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 3953937 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04731
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; 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. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO POSITION OR DIFFICULT TO REMOVE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. TEN UNUSED/STERILE DEVICES WERE RETURNED ALONG WITH THIS INCIDENT. THERE WAS NO DAMAGE NOTED TO ANY OF THE GUIDE WIRES AND ALL DIMENSIONAL AND FUNCTIONAL INSPECTIONS MET MANUFACTURING CRITERIA. IN ADDITION, CHEMICAL ANALYSIS OF ONE SAMPLE CONFIRMED THE PRESENCE OF HYDROCOAT. IN SUMMARY, THE UNUSED RETURNED DEVICES DID NOT SHOW ANY INDICATION OF DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: DIL CATH: TREK, STENT: XIENCE XPEDITION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. 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 RESISTANCE WAS FELT DURING ADVANCEMENT AND RETRACTION BETWEEN THE BALANCE MIDDLEWEIGHT GUIDE WIRE BETWEEN TREK BALLOON CATHETERS AND XIENCE XPEDITION STENT DELIVERY SYSTEMS DURING USE. IT FEELS LIKE THERE IS AN INTERACTION WITH THE GUIDE WIRE SURFACE AND THE LUMEN'S OF THE CATHETERS. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431155 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 4040771

    Patients

    Seq Age Sex Outcome Treatment
    1