BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2544774 · Received April 23, 2012

    Report

    Report Number
    2024168-2012-02596
    Event Type
    Injury
    Date Received
    April 23, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. AS THE LOT NUMBER WAS REPORTED TO BE EITHER 1090971 OR 1091673, A LOT HISTORY REVIEW WAS PERFORMED FOR BOTH LOT NUMBERS REPORTED. THE RESULTS, EXPIRATION DATE, AND DEVICE MANUFACTURE DATE WERE THE SAME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CRITICALLY STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), AND IN THE BIFURCATION OF THE ATRIOVENTRICULAR AND POSTERIOR DESCENDING ARTERIES. THE VESSEL WAS CALCIFIED. TWO BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRES WERE BEING USED, WITH ONE IN THE MAIN BRANCH AND ONE IN THE SIDE BRANCH, CLOSE TO THE LESION. A STENT WAS DEPLOYED IN THE MAIN BRANCH, AND THE GUIDE WIRE WAS REMOVED FROM THAT VESSEL. AN ATTEMPT WAS MADE TO REMOVE THE BMW GUIDE WIRE FROM THE SIDE BRANCH; HOWEVER, RESISTANCE WAS MET, AND IT WAS OBSERVED THAT THE GUIDE WIRE WAS JAILED WITH THE IMPLANTED STENT. AFTER A COUPLE ATTEMPTS TO REMOVE THE GUIDE WIRE, IT WAS FOUND THAT A PORTION OF THE GUIDE WIRE WAS BROKEN AND REMAINED IN THE ANATOMY. A STENT WAS IMPLANTED IN THE PROXIMAL RCA LESION. THE PROCEDURE WAS COMPLETED WITH A PORTION OF THE GUIDE WIRE LEFT IN THE ANATOMY; HOWEVER, THE PROCEDURE OUTCOME WAS GOOD AND THE PATIENT WAS DISCHARGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 Required Intervention BMW GUIDE WIRE