BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2882741 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08240
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE AND DIFFICULTY POSITIONING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. SORTANA PENETRATION CATHETER. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 014 HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED INTO AN UNSPECIFIED 6FR GUIDING CATHETER AND TOWARD A HEAVILY CALCIFIED, CONCENTRIC, 90% STENOSED LESION IN THE HEAVILY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA), HOWEVER, THE BMW ELITE GUIDE WIRE WAS UNABLE TO CROSS THE LESION DUE TO PATIENT ANATOMICAL CONDITIONS. THE BMW ELITE GUIDE WIRE WAS SUBSEQUENTLY WITHDRAWN FROM THE ANATOMY AND A NON-ABBOTT GUIDE WIRE WAS ADVANCED, BUT ALSO FAILED TO CROSS THE LESION. WHILE OUTSIDE OF PATIENT ANATOMY, THE PROXIMAL END OF THE BMW ELITE GUIDE WIRE WAS THEN INSERTED INTO THE DISTAL END OF A NON-ABBOTT PENETRATION CATHETER, HOWEVER THE BMW ELITE WAS UNABLE TO BE FURTHER INSERTED INTO THE PENETRATION CATHETER ONCE THE ENTIRE SECTION OF THE PROXIMAL AREA OF THE BMW ELITE WAS ADVANCED IN THE NON-ABBOTT PENETRATION CATHETER; THOUGH STRONG FORCE WAS NOT APPLIED, DURING THE INSERTION, THE GUIDE WIRE SEPARATED APPROXIMATELY 20 CENTIMETERS PROXIMAL TO TIP. THE GUIDE WIRE WAS RETRACTED FROM THE PENETRATION CATHETER WITHOUT RESISTANCE. AS THE RESISTANCE AND SEPARATION ISSUES OCCURRED WHILE OUTSIDE OF THE PATIENT ANATOMY, THERE WERE NO ADVERSE PATIENT EFFECTS CAUSED BY THE DEVICE. THE PROCEDURE WAS CONTINUED USING A NEW NON-ABBOTT GUIDE WIRE WITH THE NON-ABBOTT PENETRATION CATHETER AND A NON-ABBOTT BUDDY WIRE, WHICH WERE ABLE TO CROSS THE LESION. A 1.2X6MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC) AND A 2.25X15MM NON-ABBOTT BDC WERE EACH ABLE TO CROSS THE MID RCA LESION, BUT WERE EACH UNABLE TO CROSS THE DISTAL RCA LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091003

    Patients

    Seq Age Sex Outcome Treatment
    1