BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT POWERTURN

    MDR report key: 3140387 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03414
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K112957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MODERATELY TORTUOUS, 95% STENOSED, MID LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN ATTEMPTING TO PLACE THE GUIDE WIRE INTO THE DISTAL LAD, THE GUIDE WIRE CONSISTENTLY SLIPPED IN THE SEPTALS RATHER THAN TRACKING IN THE MAIN BRANCH OF THE VESSEL. IT WAS BELIEVED THAT THIS POSED A HIGH RISK OF DISSECTION DUE TO TIP LOAD. THE GUIDE WIRE WAS RETRACTED AND DISCARDED. A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241583 HT POWERTURN GUIDE WIRE DQX AV-TEMECULA-CT 3020501

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR