BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2032113 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02091
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE BALLOON WITH A STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED, DAMAGE TO THE BALLOON, BALLOON REFOLD, KINKS, BENDS, OBSTRUCTIONS IN THE INTRODUCER SHEATH LUMEN, OR DAMAGE TO THE INTRODUCER SHEATH. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL BALLOON CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE. IN THIS CASE, IT WAS REPORTED THAT THE BALLOON WINGED. BALLOON WINGING MAY BE THE RESULT OF THE BALLOON MATERIAL INTERACTING WITH ASSOCIATED DEVICES, INTRODUCER SHEATH AND/OR ANATOMY DISRUPTING THE TRI-FOLD AND CAUSING THE BALLOON TO DEFLATE FLAT. MULTIPLE INFLATIONS MAY ALSO CAUSE THE BALLOON MATERIAL TO REFOLD FLAT. THE FOX PLUS INSTRUCTIONS FOR USE (IFU) STATES: PLEASE NOTE THAT IF MULTIPLE BALLOON-INFLATIONS AND DEFLATIONS HAVE TAKEN PLACE, SOME RESISTANCE CAN OCCUR UPON DEVICE WITHDRAWAL. IN THIS CASE, THE DIFFICULTY REMOVING RESULTING IN HEMATOMA APPEARS TO BE CAUSED BY USING THE FOX PLUS WITHOUT AN INTRODUCER SHEATH. THE IFU WARNS: THE MINIMAL ACCEPTABLE SHEATH FRENCH SIZE IS PRINTED ON THE PACKAGE LABEL. DO NOT ATTEMPT TO PASS THE FOX PLUS THROUGH A SMALLER SIZED SHEATH INTRODUCER THAN INDICATED ON THE LABEL. ADDITIONALLY, THE IFU INSTRUCTS: MAINTAINING A VACUUM IN THE BALLOON, WITHDRAW THE CATHETER. NOTE: GENTLE COUNTERCLOCKWISE TWISTING MOTION OF THE BALLOON MAY EASE WITHDRAWAL THROUGH THE SHEATH OR FROM THE PERCUTANEOUS ENTRY SITE. IF THE BALLOON CANNOT BE WITHDRAWN THROUGH THE SHEATH, WITHDRAW THE CATHETER AND SHEATH AS ONE UNIT. HEMATOMA IS LISTED IN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE PRODUCT. OVERALL, THE DIFFICULTY REMOVING, BALLOON WINGING AND HEMATOMA AT THE ENTRY SITE ARE LIKELY DUE TO THE USE OF THE FOX PLUS WITHOUT AN INTRODUCER SHEATH. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FOX PLUS WAS BEING USED WITHOUT A SHEATH. WHEN THE BALLOON WAS DEFLATED, THE BALLOON WAS WINGED; RESULTING IN A HEMATOMA AT THE ACCESS SITE UPON REMOVAL. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO ADDITIONAL TREATMENT REQUIRED. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention