BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2171667 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05071
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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). RESISTANCE BETWEEN DEVICES CAN OCCUR DUE TO NUMEROUS FACTORS INCLUDING, 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 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. ADDITIONALLY, IN CERTAIN CIRCUMSTANCES, SUCH AS DURING MANIPULATION THROUGH TORTUOUS AND/OR TIGHT LESIONS, WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCE BETWEEN DEVICES CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND COULD LEAD TO RESISTANCE. THE GUIDE WIRE AND THE BALLOON CATHETER WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. 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 FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIL CATH: LIFESPEAR 2.0 MM. GUIDE CATH: MACH 1 FL4. STENT: LIBERTE 3.0 X 12 MM. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WITH MILD TORTUOSITY AND MILD CALCIFICATION. AFTER PRE-DILATATION WITH A 2.5 MM NON-ABBOTT BALLOON, A 3.0 X 12 MM NON-ABBOTT STENT WAS IMPLANTED. THEN THE WHISPER MS CROSSED TO THE 1ST DIAGONAL AND A 2.0 MM NON-ABBOTT BALLOON WAS ADVANCED TO DILATATE THE ENTRANCE TO THE 1ST DIAGONAL. HOWEVER DURING ADVANCEMENT OF THE NON-ABBOTT BALLOON, RESISTANCE WAS MET WITH THE BALLOON'S GUIDE WIRE LUMEN IN WHICH THE WHISPER WAS INSERTED. RESISTANCE WAS NOTED DURING ADVANCEMENT AND DURING REMOVAL. THE BALLOON WAS ABLE TO BE REMOVED FROM THE WHISPER. THE GUIDE WIRE WAS CHANGED TO A NON-ABBOTT GUIDE WIRE AND DILATATION WAS COMPLETED. THE PROCEDURE WAS COMPLETED WITHOUT ANY DIFFICULTIES. NO ADVERSE PATIENT EFFECTS WERE 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 0100702

    Patients

    Seq Age Sex Outcome Treatment
    1