BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 3830698 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03309
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DAMAGE TO THE BALLOON WAS ABLE TO BE CONFIRMED. THE DIFFICULTY ADVANCING AND REMOVING FROM THE STENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE REPORTED PUNCTURE IN THE BALLOON WAS NOT CONFIRMED. BASED ON A VISUAL AND DIMENSIONAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A LEFT FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY TORTUOUS, HEAVILY CALCIFIED, RIGHT SUPERFICIAL FEMORAL ARTERY THE FOX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND THE BALLOON BECAME BUNCHED OR FOLDED WHILE BEING POSITIONED AT THE LESION AND BECAME CAUGHT WITH THE DEPLOYED STENT. WHILE ATTEMPTING TO REPOSITION THE UNSPECIFIED GUIDE WIRE, THE GUIDE WIRE EXITED THE SIDE OF THE BALLOON. MANIPULATION OF THE BDC COULD NOT FREE THE DEVICE AND IT WAS ADVANCED AND A SLIGHT INFLATION OF 3 ATMOSPHERE (ATM) WAS PERFORMED AND THE BALLOON WAS REFOLDED WITH THE DEFLATION. THE BDC WAS ABLE TO BE REMOVED WITH THE GUIDE WIRE THROUGH THE GUIDE CATHETER WITHOUT REPORTED ISSUE. ALTHOUGH THE PROCEDURE WAS DELAYED ABOUT 5 ADDITIONAL MINUTES THE PATIENT REMAINED IN STABLE CONDITION AND NO INTERVENTION WAS REQUIRED. THE VESSEL WAS REWIRED AND A 6 X 10 MM FOX PLUS BDC WAS USED SUCCESSFULLY IN THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO REPORTED ISSUE WITH THE DEPLOYED STENT IMPLANT AND THE VESSEL. 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
    308827 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 812771

    Patients

    Seq Age Sex Outcome Treatment
    1