BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 4222151 · Received November 3, 2014

    Report

    Report Number
    2024168-2014-07189
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED CRACK IN THE HUB WAS NOT CONFIRMED; HOWEVER, THE LEAK WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS 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 THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, RESTENOSED POPLITEAL ARTERY THE FOX SV BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR POST-DILATATION OF THE VESSEL WHEN LEAKAGE AND A CRACK AT THE HUB WAS NOTED. THE SAME BDC HAD BEEN USED AT NOMINAL PRESSURE FOR PRE-DILATATION WITHOUT REPORTED ISSUE. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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
    702997 FOX SV PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 764575

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR