BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3841418 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03482
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 9, 2014
    Report Date
    April 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE STRETCHED COILS WERE CONFIRMED. BASED ON A VISUAL INSPECTION 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. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKAGING AND PRIOR TO USE THE BALANCE MIDDLEWEIGHT GUIDE WIRE WAS FOUND TO BE DAMAGED WITH THE DISTAL TIP COILS STRETCHED. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS NOT USED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THE CORE AND SHAPING RIBBON ARE SEPARATED AND THE TIP COILS ARE STRETCHED OUT, BUT STILL INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318040 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 3081671

    Patients

    Seq Age Sex Outcome Treatment
    1