BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3171251 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03764
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CALCIFIED UNSPECIFIED ARTERY THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE BMW WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. OUTSIDE THE ANATOMY IT WAS NOTED THAT THE UNSPECIFIED COATING BETWEEN THE AREA OF THE J-PORTION AND THE SHAFT WAS MISSING; NO FRAGMENT OF THE COATING REMAINED IN THE PATIENT ANATOMY. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY BY USING A SECOND BWM GUIDE WIRE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271643 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 3010871

    Patients

    Seq Age Sex Outcome Treatment
    1