BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2143430 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04549
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DIL CATH: 2.0 MM GUIDELINER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE GUIDELINER WAS PREVIOUSLY REPORTED AS A DILATATION CATHETER BUT SHOULD HAVE BEEN REPORTED AS A GUIDING CATHETER. CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY A CLINICAL SPECIALIST. THE REVIEWER NOTED THAT THE CINES ARE UNABLE TO CONCLUSIVELY SHOW THE EVENTS REPORTED ALTHOUGH THEY ARE CONGRUENT WITH THE STATEMENTS MADE. IN SHOT 29, THE DISTAL TIP OF THE WIRE(S) IS NOT ABLE TO BE VISUALIZED BUT THE INTENSITY OF THE WIRE RADIOPACITY INDICATES THAT IT IS POSSIBLE THAT THERE ARE STILL TWO WIRES WITHIN THE ARTERY. IT IS PROBABLE THAT THE WIRE AND BALLOON WERE REMOVED AS A SYSTEM. THE INTRODUCTION OF AN ADDITIONAL WIRE IN RUN 28 CLEARLY INDICATES THAT THERE IS AN ISSUE IN WHICH ADDITIONAL MEASURES FOR SUPPORT WERE REQUIRED. RESISTANCE BETWEEN DEVICES, SUCH AS THE REPORTED GUIDE WIRE BECOMING STUCK INSIDE A NON-ABBOTT BALLOON CATHETER, 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 WIRE CAN BE A FACTOR IN REDUCING CLEARANCE. ADDITIONALLY, IN CERTAIN CIRCUMSTANCES, SUCH AS DURING HIGH PRESSURE BALLOON INFLATIONS, 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. IN THIS CASE, THE LESION WAS DESCRIBED AS HEAVILY CALCIFIED AND 94% STENOSED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE GUIDE WIRE AND THE NON-ABBOTT 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 A 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER AND PERFORMS A 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 FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED. THE REPORTED DIFFICULTIES APPEAR 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 DURING THE PROCEDURE FOR TREATMENT OF A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION, THE PHYSICIAN USED A BALANCE MIDDLEWEIGHT GUIDE WIRE TO CROSS THE LESION FOLLOWED BY A NON-ABBOTT 2.0 DILATATION CATHETER TO DILATE THE PROXIMAL SEGMENT. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DILATATION CATHETER OVER THE GUIDE WIRE. AFTER DILATATION OF THE PROXIMAL SEGMENT, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DILATATION CATHETER TO THE DISTAL SEGMENT OF THE LESION. A NON-ABBOTT BUDDY WIRE WAS ADVANCED, BUT THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE NON-ABBOTT BALLOON. THE BALLOON AND THE BALANCE MIDDLEWEIGHT GUIDE WIRE WERE REMOVED AS A SINGLE UNIT WITH RESISTANCE, USING FORCE. NO STENTS WERE DEPLOYED FOR TREATMENT OF THE LESION AND NO FURTHER ANGIOPLASTY WAS PERFORMED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR