BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2180274 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05267
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    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. DILATATION CATHETER: SAPPHIRE 2.0 X 15 MM. GUIDE CATHETER: PROFIT JR4. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED NO BLOOD OR CONTRAST VISIBLE. IT IS POSSIBLE THAT THE GUIDE WIRE WAS WIPED DOWN PRIOR TO SHIPMENT TO ABBOTT VASCULAR FOR EVALUATION. THE BALLOON CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. RESISTANCE BETWEEN DEVICES CAN OCCUR DUE TO, BUT ARE NOT LIMITED TO, INTERACTION WITH OTHER DEVICES, INSERTION/REMOVAL/PREPARATION TECHNIQUE, LESION MORPHOLOGY, PATIENT ANATOMY/DISEASE STATE, THE CONDITION OF THE CATHETER BEING USED, AND/OR CONDITION OF THE WIRE COATING. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE CATHETER OR ON THE GUIDE WIRE CAN BE A FACTOR IN REDUCING CLEARANCE. ANALYSIS COULD NOT CONFIRM THE REPORTED DIFFICULTY AS THE GUIDE WIRE WAS BACKLOADED THROUGH A NEW BALLOON CATHETER AND REMOVED WITH NO RESISTANCE NOTED. THE OUTER DIAMETER OF THE GUIDE WIRE WAS MEASURED AND MET MANUFACTURING CRITERIA. IN THIS CASE, THE BALLOON CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. ANALYSIS ALSO NOTED STRANDS OF FIBERS AND DEBRIS ON THE ENTIRE LENGTH OF THE POLYMER. IT IS POSSIBLE THAT THE GUIDE WIRE MAY HAVE BEEN WIPED DOWN USING A WIPE AFTER THE PROCEDURE, WHICH COULD HAVE LEFT FIBERS ON THE POLYMER COATING AS THERE WAS NO REPORTED DAMAGE DURING INSPECTION PRIOR TO USE. SAMPLES OF THE FIBERS FOUND ON THE GUIDE WIRE WERE SENT TO THE CHEMICAL LAB FOR FURTHER ANALYSIS AND RESULTS INDICATE THAT ALL FIBERS PRESENT ON THE POLYMER COATING RESEMBLE A TYPE OF CELLULOSE FIBER WITH ORIGIN REMAINING AS UNKNOWN. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, 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. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DIFFICULTY AND THE NOTED FIBERS ON THE GUIDE WIRE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MID CALCIFICATION. THE WHISPER GUIDE WIRE WAS DELIVERED TO THE LESION AND PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. AFTER DILATATION WAS PERFORMED, AN ATTEMPT WAS MADE TO REMOVE THE BALLOON; HOWEVER, IT COULD NOT BE REMOVED FROM THE WHISPER GUIDE WIRE. THE DEVICES WERE REMOVED AS A UNIT, AND A NEW GUIDE WIRE WAS USED WITH THE SAME BALLOON. IT WAS NOTED THAT THE GUIDE WIRE COATING MAY HAVE BECOME WORN. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 1042702

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR