BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 3143535 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03468
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEFLATION DIFFICULTIES AND BALLOON REFOLD WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL 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. 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 POPLITEAL ARTERY. PRE-DILATATION WAS PERFORMED WITH 5 X 120 MM FOX SV BALLOON CATHETER. THERE WAS DIFFICULTY DEFLATING THE BALLOON AND THE BALLOON REFOLDED POORLY. A NON-ABBOTT STENT WAS IMPLANTED AND THE SAME FOX SV WAS USED FOR POST-DILATATION TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243545 FOX SV PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 815741

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: 7F COOK