BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3150792 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03547
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS, WHICH CONFIRMED A LEAK FROM THE GLUE PORT OF THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS (NCMR) OR EXCEPTIONS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATIONS. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER SIMILAR INCIDENTS ASSOCIATED WITH THIS LOT. POTENTIAL FACTORS THAT COULD CAUSE THIS TYPE OF LEAK INCLUDE, BUT ARE NOT LIMITED TO DAMAGE TO THE SIDEARM/INFLATION LUMEN DURING USE OR INSUFFICIENT ADHESIVE AT THE INFLATION LUMEN/SIDEARM JUNCTION. BASED ON A PRELIMINARY INVESTIGATION, THERE IS NO INDICATION THAT THE LARGER POPULATION OF PRODUCT IS AFFECTED, AS THIS APPEARS TO BE AN ISOLATED INCIDENT. THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DILATATION IN THE MID FEMORAL ARTERY, A 5.0X60X80 FOXCROSS BALLOON WAS INFLATED TO 9 ATMOSPHERES WITH GOOD FINAL ANGIOGRAPHIC RESULTS ALTHOUGH CONSTANT ADJUSTING OF THE BALLOON PRESSURE (USING AN INFLATION DEVICE) WAS NECESSARY DUE TO LEAKING AT THE HUB OF THE DEVICE. THE BALLOON WAS COMPLETELY DEFLATED AFTER DILATATION AND WITHDRAWN THROUGH A 5F SHEATH WITHOUT ANY UNUSUAL RESISTANCE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250250 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 812100

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 5F, INFLATION DEVICE