BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2102445 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03682
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, CONSISTENT WITH THE REPORTED USE OF THE PRODUCT. THERE WAS CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON WAS RETURNED IN A TRI-FOLD LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED AS REPORTED. THERE WAS A BEND IN THE MIDDLE OF THE TIP AND A KINK IN THE SHAFT 49 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE INTRODUCER USED DURING THE PROCEDURE WAS NOT RETURNED. A 5 FR SHEATH WAS NOT AVAILABLE FOR THE FUNCTIONAL TEST. POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE BALLOON NOT BEING FULLY DEFLATED, DAMAGE TO THE BALLOON, BALLOON REFOLD, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, OR DAMAGE TO THE GUIDING CATHETER. 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. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. IN THIS CASE, IT MAY BE POSSIBLE THAT THE BEND IN THE MIDDLE OF THE TIP AND KINK IN THE SHAFT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. HOWEVER, THIS COULD NOT BE CONFIRMED. ALTHOUGH A CAUSE FOR THE KINK AND BEND COULD NOT BE DETERMINED, ANATOMICAL CONDITIONS MAY BE A POSSIBLE FACTOR. HOWEVER, THE ANATOMICAL INFORMATION WAS NOT PROVIDED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL DILATATION IN AN UNSPECIFIED VESSEL USING A FOX PLUS DILATATION CATHETER, AN ATTEMPT WAS MADE TO WITHDRAW THE CATHETER THROUGH A 5F SHEATH; HOWEVER, THE CATHETER COULD NOT ENTER THE SHEATH. THE DEVICES WERE SUCCESSFULLY REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, 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 702043

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 5F