BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 6785280 · Received August 10, 2017

    Report

    Report Number
    2024168-2017-06551
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    July 16, 2017
    Report Date
    October 3, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURE AND EXPIRATION DATES ARE REPORTED AS UNKNOWN BECAUSE 2 POTENTIAL LOT NUMBERS WERE PROVIDED; THEREFORE, THE INFORMATION IS AS FOLLOWS: LOT: 7062171, DATE OF MANUFACTURE: 06/21/2017, EXPIRATION DATE: (B)(6) 2019. LOT: 7041771, DATE OF MANUFACTURE: 04/17/2017, EXPIRATION DATE: (B)(6) 2019. VISUAL AND DIMENSIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SEPARATION WAS CONFIRMED ALTHOUGH THE REPORTED ENTRAPMENT OF THE DEVICE COMPONENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THESE LOTS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENTS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE, TREATING A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WAS USED AND THREE STENTS WERE IMPLANTED, ONE OF WHICH WAS A 2.75 X 15 MM XIENCE ALPINE. THE GUIDE WIRE WAS REMOVED WITH RESISTANCE AND ANGIOGRAPHY NOTED THAT THE TIP OF THE GUIDE WIRE WAS TRAPPED IN THE STRUTS OF THE XIENCE ALPINE STENT AND SEPARATED, REMAINING IN THE PATIENT ANATOMY. IT WAS THOUGHT THAT THE GUIDE WIRE TIP CAUGHT ON A STENT STRUT AND SEPARATED WHEN THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY. THE GUIDE WIRE TIP WAS AGAINST THE SIDE OF THE STENT AND ADDITIONAL BALLOON INFLATIONS WERE PERFORMED TO HOLD THE WIRE FRAGMENT IN POSITION. NO ADDITIONAL ATTEMPTS WERE MADE TO REMOVE THE SEPARATED TIP. POST PROCEDURE, THE PATIENT REMAINED STABLE, WITH NO CORONARY COMPROMISE. NO DAMAGE OCCURRED WITH THE IMPLANTED 2.75 X 15 MM XIENCE ALPINE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564845 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention STENT: 2.75X15MM XIENCE ALPINE