BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2202401 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05676
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 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)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: ASTATO 30GR 0.018. GUIDE CATH: MACH 1. RESISTANCE ENCOUNTERED DURING CROSSING A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, IT IS POSSIBLE THAT THE LESION SITE WHICH WAS DESCRIBED AS MILDLY TORTUOUS AND HEAVILY CALCIFIED CONTRIBUTED TO THE RESISTANCE. 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. THERE WAS NO REPORT OF LEAKS NOTED DURING PREPARATION FOR USE, SUGGESTING THAT THE DAMAGE LIKELY OCCURRED DURING USE. IN THIS CASE, IT MAY BE POSSIBLE THAT THE BALLOON RUPTURE IS A RESULT OF INTERACTION BETWEEN THE BALLOON MATERIAL AND THE LESION SITE, WHICH WAS DESCRIBED AS HEAVILY CALCIFIED. 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. 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 RESISTANCE AND 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 THE PROCEDURE IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY TO TREAT A CHRONIC TOTAL OCCLUSION, A NON-ABBOTT GUIDE WIRE WAS ADVANCED ACROSS THE TARGET LESION. THE FOXCROSS DILATATION CATHETER WAS THEN ADVANCED AND RESISTANCE WAS FELT, BUT WAS ABLE TO CROSS THE LESION WITHOUT ANY APPLIED FORCE. DURING DILATATION, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS. THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY AND A NON-ABBOTT BALLOON WAS USED FOR DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. 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 696775

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR