BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

    MDR report key: 8181007 · Received December 19, 2018

    Report

    Report Number
    2024168-2018-09879
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 11, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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: GUIDE WIRE: SION BLUE, RUNTHROUGH NS; GUIDE CATHETER: HYPERION JR 4.0 6F, HYPERION JR 4.0SH 8F; STENT: 4.0X21 ULTIMASTER, 3.5X26 ORSIRO. (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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DETACHMENT AND STRETCHED WERE ABLE TO BE CONFIRMED. THE REPORTED FAILURE TO ADVANCE, ENTRAPMENT AND DEVICE DAMAGED BY ANOTHER DEVICE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE HI-TORQUE TURNTRAC GUIDE WIRE INSTRUCTIONS FOR USE (IFU) STATES: USE EXTREME CAUTION WHEN MOVING A GUIDE WIRE THROUGH A NON-ENDOTHELIALIZED STENT, OR THROUGH STENT STRUTS, INTO A BIFURCATED VESSEL. USE OF THIS TECHNIQUE INVOLVES ADDITIONAL PATIENT RISKS, INCLUDING THE RISK THAT THE WIRE MAY BECOME CAUGHT ON THE STENT STRUT. DO NOT: PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. 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. 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 AND SUBSEQUENT DEVIATION OF THE IFU AS IT IS LIKELY THAT AS THE GUIDE WIRE WAS ADVANCED THROUGH THE SIDE STRUTS OF THE NON-ABBOTT STENT RESISTANCE WAS MET WITH THE SIDE STRUTS OF THE NON-ABBOTT STENT RESULTING IN THE REPORTED FAILURE TO ADVANCE AND RESULTED IN THE REPORTED ENTRAPMENT. ATTEMPTED REMOVAL OF THE GUIDE WIRE USING FORCE (AGAINST THE IFU) RESULTED IN THE REPORTED DAMAGE TO THE DEPLOYED STENT, THE REPORTED STRETCHED COILS AND ULTIMATELY RESULTED IN THE REPORTED/NOTED DETACHMENTS (TIP/CORE, COIL). THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY, NO CALCIFICATION AND 90% STENOSIS. A 3.5 X 26 MM NON-ABBOTT STENT WAS DEPLOYED AT THE BIFURCATION OF THE RIGHT VENTRICLE BRANCH OF THE DISTAL RCA. A HI-TORQUE TURNTRAC FLEX GUIDE WIRE WAS ADVANCED WITH RESISTANCE THROUGH THE SIDE STRUTS OF THE NON-ABBOTT STENT TO THE RIGHT VENTRICLE BRANCH; HOWEVER, IT BECAME STUCK POSSIBLY WITH THE STENT BUT THIS COULD NOT BE CONFIRMED. ON ATTEMPTED REMOVAL OF THE GUIDE WIRE WITH FORCE, THE DEPLOYED STENT DEFORMED AND THE GUIDE WIRE TIP SEPARATED. THE COILS UNRAVELED AND REMAINED FROM THE CORONARY ARTERY TO RADIAL ACCESS SITE. AN ADDITIONAL 3.5 X 40 MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE DEFORMED STENT AND CRUSH THE SEPARATED GUIDE WIRE TIP TO THE VESSEL WALL. THE PATIENT WAS REPORTED TO BE WELL POST PROCEDURE. THE DAY POST PROCEDURE, A PART OF THE SEPARATED GUIDE WIRE PROTRUDED OUT OF THE RADIAL ACCESS SITE AND THE PART WAS SIMPLY CUT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018376 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 8052461

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES