BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 8317413 · Received February 7, 2019

    Report

    Report Number
    2024168-2019-00943
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 15, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED PHYSICAL PROPERTY ISSUE/SWOLLEN WAS ABLE TO BE CONFIRMED. THE REPORTED DIFFICULT TO REMOVE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRES INSTRUCTIONS FOR USE (IFU) WARNINGS SECTION STATES: DO NOT: PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. DO NOT: TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. 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 INCIDENTS FROM THIS LOT. AS THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE, THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT DURING REMOVAL INTERACTION WITH THE STENT STRUTS RESULTED IN THE REPORTED DIFFICULTY TO REMOVE. MANIPULATION OF THE DEVICE BY APPLYING TORQUE (FORCE), AGAINST THE IFU, LIKELY RESULTED IN THE REPORTED PHYSICAL PROPERTY ISSUE/SWOLLEN AND THE NOTED STRETCHED COATING. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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: DILATATION CATHETER: 3.5 MM NON COMPLIANT BALLOON, RYUREI 2.25 X15; GUIDE WIRE: SION BLUE, FIELDER; GUIDE CATHETER: HYPERION 7F SPB 3.5; STENT: XIENCE SIERRA 3.0 X28, 3.5 X 23. (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 PERFORMED TO TREAT AN ECCENTRIC, DE NOVO LESION IN THE LEFT MAIN TO LEFT ANTERIOR DESCENDING CORONARY (LAD) ARTERY WITH NO TORTUOSITY, MODERATE CALCIFICATION AND 75% STENOSIS. A 3.0 X 28 MM XIENCE SIERRA STENT WAS DEPLOYED AT THE PROXIMAL LAD AND A 3.5 X 23 MM XIENCE SIERRA WAS DEPLOYED AT THE LEFT MAIN TO LAD. A 014 HI TORQUE PILOT 50 GUIDE WIRE WAS ADVANCED THROUGH THE SIDE STRUTS OF THE 3.5 X 23 MM STENT TO THE LEFT CIRCUMFLEX (LCX) ARTERY. A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LCX BUT FAILED TO CROSS THE STENT STRUTS. THE LEFT MAIN TO LAD ARTERY WAS FURTHER DILATED WITH A 3.5 MM NON-ABBOTT BDC. THE PILOT GUIDE WIRE WAS ATTEMPTED TO BE REMOVED FROM THE LCX; HOWEVER, MET RESISTANCE WITH THE STENT STRUTS. A NON-ABBOTT MICROCATHETER WAS ATTEMPTED TO BE ADVANCED TO AID REMOVAL OF THE GUIDE WIRE; HOWEVER, ALSO FAILED TO CROSS THE STENT STRUTS. THE GUIDE WIRE WAS ULTIMATELY REMOVED BY APPLYING TORQUE [FORCE]. ON REMOVAL OF THE GUIDE WIRE FROM THE ANATOMY, THE POLYMER TIP WAS NOTED TO BE SWOLLEN [IRREGULAR APPEARANCE]. IT WAS THOUGHT THAT THE POINT ON THE GUIDE WIRE THAT MET RESISTANCE WITH THE STENT STRUTS WAS PROXIMAL TO THE SWELLING POINT. THERE WAS NO REPORTED DAMAGE TO THE DEPLOYED STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DILATATION OF THE LCX WITH A NON-ABBOTT BDC. 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
    108546 HI-TORQUE PILOT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 8080971

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention