BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2180480 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05321
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST IN THE BALLOON, CONSISTENT WITH A LEAK OR RUPTURE WHILE IN THE ANATOMY. THERE WAS BLOOD IN THE HUB. THE BALLOON WAS LOOSELY FOLDED. DURING FUNCTIONAL TESTING, AN INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON BUT THE BALLOON WOULD NOT PRESSURIZE. AFTER THE BALLOON CATHETER WAS LEFT PRESSURIZED TO DISSOLVE THE BLOOD AND CONTRAST IN THE BALLOON AND BLOOD IN THE HUB, A LONGITUDINAL RUPTURE WAS OBSERVED IN THE ENTIRE WORKING LENGTH OF THE BALLOON. THERE WERE NO SCRATCHES VISIBLE. HERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. SCANNING ELECTRON MICROSCOPY ANALYSIS WAS PERFORMED. AND THE RESULTS INDICATE THAT THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. IN THIS CASE, THERE WAS NO REPORT OF LEAKS NOTED DURING THE PREPARATION FOR USE, SUGGESTING THAT THE BALLOON DAMAGE OCCURRED DURING USE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE BALLOON. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING DATA MET THE MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOX CROSS BALLOON RUPTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 706186

    Patients

    Seq Age Sex Outcome Treatment
    1