BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2122401 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04157
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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. INDICATIONS FOR USE, FAILURE TO FOLLOW STEPS, AND AGAINST RESISTANCE ESTIMATED DATE (REPORTED AS OCCURRING WEEK OF (B)(6) 2011). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. GUIDE WIRE BECOMING STICKY CAN OCCUR DUE TO, BUT NOT LIMITED TO MANUFACTURING, INSUFFICIENT HYDROPHILIC COATING AND/OR THE GUIDE WIRE NOT BEING THOROUGHLY HYDRATED DURING PREPARATION PRIOR TO USE. REPORTEDLY, THE INEXPERIENCED ELECTROPHYSIOLOGIST WAS POSSIBLY USING INSUFFICIENTLY HYDRATED GUIDE WIRE AND IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE (IFU) PREPARATION FOR USE FOR HI-TORQUE GUIDE WIRES WITH HYDROPHILLIC COATING; STEP 1. BEFORE REMOVING THE GUIDE WIRE FORM THE DISPENSER, INJECT NORMAL SALINE INTO THE HUB END OF THE DISPENSER TO THOROUGHLY WET THE COMPLETE SURFACE OF THE GUIDE WIRE. THE IMPROPER USE OF THE GUIDE WIRE LIKELY CONTRIBUTED TO THE REPORTED "STICKY" SURFACE OF THE GUIDE WIRE AND LIKELY RESULTED IN THE REPORTED RESISTANCE ON ADVANCEMENT AND ON REMOVAL OF THE GUIDE WIRE. ADDITIONALLY, IT WAS REPORTED THAT WHEN THE GUIDE WIRE MET RESISTANCE DURING ADVANCEMENT AND REMOVAL, THE GUIDE WIRE WAS STILL USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE IFU WARNING SECTION STATES: DO NOT: 1) PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. 2) TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. 3) ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. 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 THAT CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. THE IMPROPER METHOD LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES EXPLAINED ABOVE. REPORTEDLY, THE GUIDE WIRE WAS USED DURING PLACEMENT OF A PACEMAKER LEAD AND IT SHOULD BE NOTED IN THE IFU INTENDED USE SECTION: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). IT IS UNKNOWN IF THE USE OF THE GUIDE WIRE TO PLACE A PACEMAKER LEAD CONTRIBUTED TO THE REPORTED DIFFICULTIES ABOVE. OVERALL, THE REPORTED STICKY TEXTURE AND RESISTANCE DURING ADVANCEMENT AND REMOVAL OF THE GUIDE WIRE APPEARS TO BE RELATED TO USER IMPROPER METHOD AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THIS REPORTED ISSUE WILL CONTINUE TO BE MONITORED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED. MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. INDICATIONS FOR USE, FAILURE TO FOLLOW STEPS, AND AGAINST RESISTANCE ESTIMATED DATE (REPORTED AS OCCURRING WEEK OF (B)(6) 2011). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. GUIDE WIRE BECOMING STICKY CAN OCCUR DUE TO, BUT NOT LIMITED TO MANUFACTURING, INSUFFICIENT HYDROPHILIC COATING AND/OR THE GUIDE WIRE NOT BEING THOROUGHLY HYDRATED DURING PREPARATION PRIOR TO USE. REPORTEDLY, THE INEXPERIENCED ELECTROPHYSIOLOGIST WAS POSSIBLY USING INSUFFICIENTLY HYDRATED GUIDE WIRE AND IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE (IFU) PREPARATION FOR USE FOR HI-TORQUE GUIDE WIRES WITH HYDROPHILLIC COATING; STEP 1. BEFORE REMOVING THE GUIDE WIRE FORM THE DISPENSER, INJECT NORMAL SALINE INTO THE HUB END OF THE DISPENSER TO THOROUGHLY WET THE COMPLETE SURFACE OF THE GUIDE WIRE. THE IMPROPER USE OF THE GUIDE WIRE LIKELY CONTRIBUTED TO THE REPORTED "STICKY" SURFACE OF THE GUIDE WIRE AND LIKELY RESULTED IN THE REPORTED RESISTANCE ON ADVANCEMENT AND ON REMOVAL OF THE GUIDE WIRE. ADDITIONALLY, IT WAS REPORTED THAT WHEN THE GUIDE WIRE MET RESISTANCE DURING ADVANCEMENT AND REMOVAL, THE GUIDE WIRE WAS STILL USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE IFU WARNING SECTION STATES: DO NOT: 1) PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. 2) TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. 3) ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. 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 THAT CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. THE IMPROPER METHOD LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES EXPLAINED ABOVE. REPORTEDLY, THE GUIDE WIRE WAS USED DURING PLACEMENT OF A PACEMAKER LEAD AND IT SHOULD BE NOTED IN THE IFU INTENDED USE SECTION: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). IT IS UNKNOWN IF THE USE OF THE GUIDE WIRE TO PLACE A PACEMAKER LEAD CONTRIBUTED TO THE REPORTED DIFFICULTIES ABOVE. OVERALL, THE REPORTED STICKY TEXTURE AND RESISTANCE DURING ADVANCEMENT AND REMOVAL OF THE GUIDE WIRE APPEARS TO BE RELATED TO USER IMPROPER METHOD AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THIS REPORTED ISSUE WILL CONTINUE TO BE MONITORED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED. MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHISPER MS GUIDE WIRE BECAME STICKY DURING PACEMAKER OR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD PLACEMENT. ALTHOUGH RESISTANCE WAS MET DURING ADVANCEMENT AND REMOVAL, THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OR THERAPY AND NO INTERVENTION WAS REQUIRED FOR THE RESISTANCE. REPORTEDLY THE PROCEDURE WAS PERFORMED BY AN ELECTROPHYSIOLOGIST, INEXPERIENCED IN THE USE OF THE WHISPER GUIDE WIRE AND THE GUIDE WIRE WAS POSSIBLY INSUFFICIENTLY HYDRATED. AFTER INSTRUCTION BY AN EXPERIENCED USER, SUBSEQUENT WHISPER GUIDE WIRES WERE SOAKED IN HEPARINIZED SALINE AND WERE USED WITHOUT ANY RESISTANCE. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1