BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    MDR report key: 2142851 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04526
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 2.0 X 12MM TREK; GUIDE CATH: EBU 3.5 5F. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 2.0 X 12MM TREK IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE NOTED BLOOD AND CONTRAST ON THE COILS WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THERE WERE OFFSET AND OVERLAPPING INTERMEDIATE COILS SPORADICALLY PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 4 MM, WHICH COULD HAVE BEEN THE REPORTED DAMAGE ON THE GUIDE WIRE, WHICH IS CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. THE BALLOON CATHETER USED IN THE PROCEDURE WAS NOT RETURNED. RESISTANCE BETWEEN DEVICES CAN OCCUR DUE TO NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, INTERACTION BETWEEN 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 RESISTANCE AS THE RETURNED GUIDE WIRE WAS BACKLOADED THROUGH A NEW TREK BALLOON CATHETER AND THERE WAS NO RESISTANCE NOTED. THE RETURNED GUIDE WIRE WAS THEN REINSERTED INTO A NEW TREK BALLOON CATHETER AND WAS PRESSURIZED TO RATED BURST PRESSURE, NEGATIVE PRESSURE WAS PULLED AND THE GUIDE WIRE WAS REMOVED FROM THE CATHETER WITH NO RESISTANCE NOTED. IN THIS CASE, THE BALLOON CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. 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 THERE IS NO INDICATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TREK 2.0 X 12MM BALLOON DILATATION CATHETER WAS BEING USED OVER A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE TREATING A LESION IN THE CIRCUMFLEX ARTERY. THE LESION WAS NOT HIGHLY CALCIFIED AND THERE WAS NO TORTUOSITY. THE TREK BALLOON WAS INFLATED ONE TIME FOR 15 SECONDS AT 14 ATMOSPHERES. RESISTANCE WAS OBSERVED WITH THE GUIDE WIRE WHEN ATTEMPTING TO REMOVE THE TREK AFTER BALLOON DEFLATION. THE DECISION WAS MADE TO REMOVE BOTH DEVICES AS A UNIT TO AVOID MORE DAMAGE TO THE GUIDE WIRE. THE ENTIRE GUIDE WIRE WAS REMOVED FROM THE PATIENT; HOWEVER, A FRACTURE WAS OBSERVED BETWEEN THE SOFT AND THE RIGID PART. THE GUIDE WIRE WAS NOT SEPARATED IN TWO PIECES. THE NON-ABBOTT 5F GUIDING CATHETER WAS LEFT IN PLACE AND ANOTHER BMW WAS INSERTED TO COMPLETE THE STENTING PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN GUIDE WIRE DQX AV-TEMECULA-CT 1012671

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR