BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE INTERMEDIATE GUIDE WIRE

    MDR report key: 3223067 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04347
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE IS BEING RETAINED AT THE SITE. 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 EVALUATION. THE REPORTED COMPLAINT RELATED TO DIFFICULTY IN MOVEMENT WITH THE CATHETER AND WIRE, WITH THE PRESENCE OF MASSES ON THE SURFACE OF CORE OF THE HT INTERMEDIATE GUIDE WIRE WAS INVESTIGATED AND IT WAS DETERMINED THAT THE MASSES WERE CLEAR DROPLETS OF HYDROCOAT PRIMER SOLUTION USED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE LOT HISTORY RECORD (LHR) FOR THE REPORTED LOT REVEALED NO NONCONFORMING MATERIAL RECORDS (NCMRS), INDICATING ALL LOT RELEASE TESTING MET SPECIFICATIONS. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE WERE NO SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR THIS DEFICIENCY. THE CAUSE OF THE MASSES WAS RELATED TO MANUFACTURING. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED AND CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE WERE PUT IN PLACE TO CORRECT THE SITUATION. THE PERFORMANCE OF THESE GUIDE WIRES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING AN UNSPECIFIED ARTERY ACCESS APPROACH DURING A PROCEDURE THE HT INTERMEDIATE GUIDE WIRE WAS POSITIONED IN THE ANATOMY AND A BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED ON THE GUIDE WIRE WHEN RESISTANCE WAS MET. THE BDC WAS BLOCKED AND COULD NOT ADVANCE FURTHER. BOTH THE BDC AND THE GUIDE WIRE WERE REMOVED FROM THE ANATOMY. OUTSIDE THE ANATOMY IT WAS NOTED THAT THE GUIDE WIRE HAD A STEP/BALL OF MATERIAL ON THE DISTAL SHAFT. A DIFFERENT SAME SIZE GUIDE WIRE WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322712 HI-TORQUE INTERMEDIATE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1083101

    Patients

    Seq Age Sex Outcome Treatment
    1