BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2770953 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06252
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 VENOUS FISTULA. THE 8 X 40 MM FOXCROSS BALLOON WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BALLOON WAS ADVANCED WITHOUT ISSUE AND INFLATED TO NOMINAL PRESSURE FOR 30 SECONDS; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. FOUR TO FIVE ATTEMPTS WERE MADE TO PULL NEGATIVE, BUT THE BALLOON COULD NOT BE DEFLATED. THE BALLOON WAS REMOVED AGAINST RESISTANCE, WHILE INFLATED, AND RUPTURED WHEN REMOVED THROUGH THE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 758801

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR