BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2133856 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04342
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ADDITIONAL ARMADA IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE ARMADA WAS NOT RETURNED FOR EVALUATION WHICH MAY HAVE AIDED IN DETERMINING A CAUSE FOR THE REPORTED RUPTURE. 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. BECAUSE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE AND THAT THE DAMAGE LIKELY OCCURRED DURING USE. IN THIS CASE, THE LESION SITE WAS DESCRIBED AS BEING HEAVILY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE BALLOON DAMAGE. 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 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. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. WITHOUT HAVING THE ARMADA TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE 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 DURING A MID POPLITEAL ARTERY STENTING PROCEDURE, IN A TOTALLY OCCLUDED RESTENOSED UNSPECIFIED STENT, TWO ARMADA BALLOONS ATTEMPTED TO PRE-DILATE THE HEAVILY CALCIFIED LESION. BOTH BALLOONS WERE TAKEN TO 14 ATMOSPHERES (ATM) WITH DIFFICULTY DURING THE FIRST INFLATION. THE BALLOONS WOULD NOT HOLD PRESSURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THE LESION WAS SUCCESSFULLY STENTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR