BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE ADVANCE GUIDE WIRE

    MDR report key: 2220962 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05921
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE CATH: HEARTRAIL 6F JR4 SH. FACTORS THAT MAY CONTRIBUTE TO RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, INNER DIAMETER OF GUIDE CATHETER, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, COAGULATION OF BLOOD OR CONTRAST, OR DAMAGE TO THE GUIDE CATHETER. THERE WAS NO REPORTED GUIDE WIRE OR GUIDE CATHETER DAMAGE DURING INSPECTION PRIOR TO USE. IT IS POSSIBLE THAT THE GUIDE WIRE WAS TRAPPED INTO THE SIDE HOLE OF THE GUIDE CATHETER AND LIKELY CAUSED THE REPORTED RESISTANCE. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE INVESTIGATION. A REVIEW OF THE LOT HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY ASSOCIATED NONCONFORMING MATERIAL RECORDS WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED INABILITY TO POSITION/RETRACT THE GUIDE WIRE. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER BEING LOADED INTO THE DISPENSER AND PERFORMS OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE OF THE MODERATELY TORTUOUS AND CALCIFIED, 90% STENOSED RIGHT CORONARY ARTERY (RCA), AN ADVANCE GUIDE WIRE CROSSED TARGET LESION AND INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED; BOTH DEVICES WERE REMOVED FROM THE ANATOMY WITHOUT INCIDENT AND THERE WAS NO REPORT OF RESISTANCE DURING REMOVAL. THUS THE ADVANCE GUIDE WIRE WAS REINSERTED AND ADVANCED TO THE TARGET LESION, HOWEVER, THE TIP INSERTED INTO THE SIDE HOLE OF THE GUIDING CATHETER AND DID NOT MOVE; THE TWO DEVICES WERE REMOVED AS A SYSTEM DUE TO RESISTANCE BEING MET. THE GUIDE WIRE WAS CHANGED TO A BALANCE. THERE WAS NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE ADVANCE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0090391

    Patients

    Seq Age Sex Outcome Treatment
    1