BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4122958 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06250
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. CONCOMITANT MEDICAL PRODUCTS: DIL CATH: 4.5X12MM NC TREK; STENT: 4.0X33MM XIENCE XPEDITION. 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 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. THE 4.5X12MM NC TREK REFERENCED, IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE MID LEFT MAIN (LM) ARTERY. A 4.0X33MM XIENCE XPEDITION STENT IMPLANT WAS SUCCESSFULLY DEPLOYED WITHOUT ANY REPORTED ISSUE. THE 4.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED AND FLUSHED PRIOR TO USE WITH NO ISSUES NOTED. RESISTANCE WAS MET DURING ADVANCEMENT OF THE NC TREK BDC ONTO THE BALANCED MIDDLE WEIGHT (BMW) GUIDE WIRE; HOWEVER, THE BDC REACHED THE TARGET LESION AND WAS SUCCESSFULLY USED TO POST-DILATATE THE DEPLOYED XIENCE XPEDITION STENT IMPLANT. RESISTANCE WAS MET DURING REMOVAL OF THE NC TREK BDC FROM THE BMW GUIDE WIRE. REPORTEDLY, THE LUMEN OF THE NC TREK BDC FELT STICKY AND WAS NOT SMOOTH. FORCE WAS USED TO REMOVE THE NC TREK BDC FROM THE WIRE, WHICH RESULTED IN THE LOSS OF WIRE POSITION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AS THE TARGET LESION WAS TREATED, THE PROCEDURE WAS COMPLETED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600829 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 4050671

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR