BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2160077 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02819
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON FOUND THAT A LONGITUDINAL TEAR WAS PRESENT IN THE BALLOON MATERIAL. THE TEAR STRETCHED FROM THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND TO 1MM DISTAL TO THE DISTAL EDGE OF THE DISTAL MARKERBAND. THE TOTAL LENGTH OF THE TEAR WAS APPROXIMATELY 16MM. AN EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011 IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE, BALLOON INFLATION DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, 27MM IN LENGTH, ECCENTRIC SHAPED, DE-NOVO TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED, NON-TORTUOUS, 3MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 15MM X 2.5MM MAVERICK 2 MONORAIL BALLOON WAS PLACED AT THE TARGET LESION FOR AND THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON SEVERAL TIMES AND THE BALLOON WOULD NOT INFLATE. THE BALLOON CATHETER WAS REMOVED AND PRE-DILATION WAS COMPLETED WITH A 2.0X15MM MAVERICK BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF A 3.0X28MM LIBERTE BARE METAL STENT IN THE LAD AND A 4.0X24MM LIBERTE BARE METAL STENT IN THE RIGHT CORONARY ARTERY (RCA) WITH NO POST-DILATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815250 13874972

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 6F MACH1 FL4 GUIDE CATHETER| PT2 GUIDE WIRE