BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2853179 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07586
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED DIFFICULTY IN POSITIONING AND REMOVING THE GUIDE WIRE WAS CONFIRMED VIA THE RETURNED DEVICE ANALYSIS. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER FLUSHING THE DEVICE, A 014 HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE (WITHOUT MARKER) WAS ADVANCED TOWARD A MILDLY CALCIFIED, CONCENTRIC, 100% STENOSED, DE NOVO LESION IN THE MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY, FOLLOWED BY ADVANCEMENT OF AN ASAHI CORSAIR MICRO CATHETER TO ASSIST THE BMW ELITE IN CROSSING THE LESION. AFTER ADVANCING THE CORSAIR OVER THE BMW ELITE, THE BMW ELITE WAS NO LONGER ABLE TO MOVE WITHIN THE CORSAIR. BOTH DEVICES WERE WITHDRAWN FROM THE ANATOMY AS A SINGLE UNIT. ONCE OUTSIDE OF THE ANATOMY, THE BMW ELITE WAS ABLE TO BE EASILY REMOVED FROM THE CORSAIR. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE BOTH DEVICES IN THE ANATOMY IN THE SAME MANNER AS BEFORE, HOWEVER, THE BMW ELITE BECAME STUCK INSIDE OF THE CORSAIR AND BOTH DEVICES WERE, AGAIN, REMOVED FROM THE ANATOMY AS A SINGLE UNIT. A NEW NON-ABBOTT GUIDE WIRE WAS ADVANCED TOWARD THE LESION, FOLLOWED BY ADVANCEMENT OF THE SAME CORSAIR, HOWEVER, THE LESION WAS UNABLE TO BE CROSSED, THUS THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 2091801

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER: ASAHI CORSAIR