BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2143297 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04542
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: TRANSCEND (0.014INCH/BSJ), RADIOFOCUS (0.035INCH/TERUMO). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BALLOON CATHETER WAS RETURNED WITHOUT BLOOD VISIBLE, SUGGESTING THE DEVICE MAY HAVE BEEN WIPED DOWN PRIOR TO RETURN. THERE WAS CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE BALLOON. DURING FUNCTIONAL TESTING, AN INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO RATED BURST PRESSURE (RBP) BUT THERE WAS FLUID LEAKING FROM THE DISTAL END OF THE TIP. AFTER THE TIP WAS PLUGGED WITH A PIN GAUGE AND THE GUIDE WIRE PORT ON THE HUB WAS PLUGGED WITH A STOPCOCK, THE BALLOON WAS INFLATED TO RBP WITH NO DAMAGE NOTED TO THE BALLOON. THERE WAS A TEAR OBSERVED IN THE INNER MEMBER PROXIMAL TO THE PROXIMAL MARKER. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. IN THIS CASE, THE LEAK NOTED FROM THE TIP OF THE CATHETER APPEARS TO BE DUE TO THE TEAR NOTED ON THE INNER MEMBER NEAR THE PROXIMAL MARKER BAND INSIDE THE BALLOON. ALTHOUGH A CONCLUSIVE CAUSE FOR THIS TEAR COULD NOT BE DETERMINED, IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH THE FIRST .014 NON-ABBOTT GUIDE WIRE DUE TO POOR GUIDE WIRE SUPPORT. THE GUIDE WIRE WAS THEN CHANGED OUT FOR A .035 NON-ABBOTT GUIDE WIRE AND THE SAME FOXCROSS WAS SUCCESSFUL IN CROSSING THE LESION. IN THIS CASE, IT MAY BE POSSIBLE THAT THE TEAR NOTED IN THE INNER MEMBER IS THE RESULT OF INTERACTION WITH THE PROXIMAL END OF THE .014 NON-ABBOTT GUIDE WIRE DURING REMOVAL, OR INTERACTION WITH THE PROXIMAL END OF THE .035 NON-ABBOTT GUIDE WIRE DURING INSERTION THROUGH THE TIP. BECAUSE IT WAS NOT REPORTED THAT THERE WAS AN INDICATION OF A LEAK PRIOR TO USE, THIS SUGGEST THAT THE DAMAGE MAY HAVE OCCURRED DURING THE GUIDE WIRE EXCHANGE. THE INITIAL LACK OF SUPPORT WITH THE .014 NON-ABBOTT GUIDE WIRE MAY BE DUE TO ANATOMICAL CONDITIONS. OVERALL, A CONCLUSIVE CAUSE FOR THE NOTED TEAR IN THE INNER MEMBER COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. 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. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVASCULARIZATION PROCEDURE OF A NON-ABBOTT STENT IN THE RIGHT BRACHIOCEPHALIC ARTERY, THE FOXCROSS BALLOON CATHETER LEAKED. THE FOXCROSS WAS ADVANCED OVER A 0.014 NON-ABBOTT GUIDE WIRE BUT COULD NOT CROSS THE LESION DUE TO POOR GUIDE WIRE SUPPORT. A .035 NON-ABBOTT GUIDE WIRE WAS USED AND THE SAME FOXCROSS WAS SUCCESSFUL IN CROSSING THE LESION. AIR AND BLOOD WERE NOTED IN THE INDEFLATOR BUT NO LEAK/RUPTURE WAS SUSPECTED FOR THE DEVICE. THE BALLOON WAS DILATATED ONCE BUT THE INFLATION WAS DIFFICULT WHEN PRESSURIZED FROM 2 TO 4 ATMOSPHERE (ATM). ON ANGIOGRAPHY THE BALLOON DID NOT SEEM TO CORRESPOND WELL WITH THE APPLIED PRESSURE. WHEN THE BALLOON REACHED 9 ATM, IT SUDDENLY INFLATED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. AS THE LESION WAS CONFIRMED NOT TO BE FULLY DILATED AFTER THE FOXCROSS WAS REMOVED,THE LESION WAS FURTHER DILATED WITH A NON-ABBOTT BALLOON CATHETER. (ONCE OUTSIDE THE ANATOMY, FURTHER EXAMINATION AND INFLATION REVEALED FLUID LEAKING FROM AROUND THE TIP AREA; THERE WAS NO INDICATION OF A LEAK PRIOR TO EXTERNAL EXAM). THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THOUGH REQUESTED, 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 658825

    Patients

    Seq Age Sex Outcome Treatment
    1