BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 2192807 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05534
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CINE IMAGES WERE RETURNED AND REVIEWED BY A CLINICAL SPECIALIST AND THE RESULTS SUGGEST THAT THE SHARP CALCIFIED PROTRUSION LOCATED AT THE MEDIAL AND PROXIMAL ASPECT OF THE MAIN LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY MAY HAVE FACILITATED THE BALLOONS TO RUPTURE. CALCIUM DEFORMATION FROM THE FIRST BALLOONS INFLATION MAY POSSIBLY HAVE ENHANCED THE PROTRUSION. IN THIS CASE, THE BALLOON RUPTURE APPEARS TO BE DUE TO INTERACTION WITH THE SHARP CALCIFICATION AT THE LESION SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED ARMADA BALLOON CATHETER FOUND BLOOD AND CONTRAST IN THE BALLOON, CONSISTENT WITH A LEAK OR RUPTURE WHILE IN THE ANATOMY. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON. FLUID LEAKED OUT OF A LONGITUDINAL RUPTURE IN THE BALLOON, 1MM IN LENGTH, 2 CM PROXIMAL TO THE DISTAL BALLOON MARKER. THERE WAS A LONGITUDINAL SCRATCH AT THE PROXIMAL END OF THE RUPTURE FOR A LENGTH OF 1 CM. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS SUGGEST THAT THE BALLOON MATERIAL FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. IN THIS CASE, THE BALLOON RUPTURE MAY BE DUE TO INTERACTION WITH THE LESION SITE, WHICH WAS DESCRIBED AS BEING HEAVILY CALCIFIED. ADDITIONALLY, IT WAS REPORTED THAT THE SECOND ARMADA 35 USED IN THIS CASE ALSO RUPTURED, FURTHER SUGGESTING THAT THE LESION SITE LIKELY CONTRIBUTED TO THE FAILURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, SUCH AS INTERACTION WITH CALCIFICATION, THIS MAY CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE. 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 (RBP) AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND REVEALED NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION TO SUGGEST A LOT SPECIFIC OR PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE REPORTED DEVICE IS NOT CURRENTLY CLEARED/APPROVED IN THE US, BUT WAS DETERMINED TO BE SAME OR SIMILAR TO A DEVICE THAT HAS BEEN CLEARED/APPROVED BY THE FDA. THE 6 X 120 ARMADA 35 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION. A 6 X 200 ARMADA 35 WAS ADVANCED AND INFLATED TO 8 ATMOSPHERES (ATM) SUCCESSFULLY. A 6 X 80 ARMADA 35 WAS THEN ADVANCED; HOWEVER, A BALLOON RUPTURE OCCURRED DURING THE FIRST INFLATION OF 8 ATM. A 6 X 120 ARMADA 35 WAS ADVANCED TO THE LESION, BUT THIS BALLOON ALSO RUPTURED DURING THE FIRST INFLATION, AT 10 ATM. A 7 X 40 ARMADA 35 WAS THEN USED FOR DILATATION SUCCESSFULLY, WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 735483

    Patients

    Seq Age Sex Outcome Treatment
    1 6 X 120 ARMADA 35