BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 3800972 · Received May 8, 2014

    Report

    Report Number
    2024168-2014-02952
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR BALLOON RUPTURE INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 20MM CONCENTRIC DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH 90% STENOSIS AND MODERATE CALCIFICATION. THE 4.0X20MM FOX SV BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND INFLATED, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 20 ATMOSPHERES. THE DEVICE WAS REMOVED AND A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277190 FOX SV PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 745299

    Patients

    Seq Age Sex Outcome Treatment
    1