BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3260142 · Received August 1, 2013

    Report

    Report Number
    2134265-2013-05072
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    May 7, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED NO KINKS ALONG THE SHAFT. THERE WAS A BUILD-UP OF SOLIDIFIED BLOOD INSIDE THE BALLOON. AN EXAMINATION OF THE TIP FOUND THAT THE DISTAL EDGE OF THE TIP WAS JAGGED IN APPEARANCE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND DURING AN ATTEMPT TO INFLATE THE BALLOON, A PINHOLE LEAK WAS IDENTIFIED AT THE PROXIMAL EDGE OF CENTER MARKERBAND. AN EXAMINATION OF THE MARKERBAND IDENTIFIED NO ISSUES. 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)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. A 1.50MM X 15MM MAVERICK² BALLOON CATHETER WAS ADVANCED, BUT UNABLE TO CROSS THE LESION. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360570 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815150 0015569267

    Patients

    Seq Age Sex Outcome Treatment
    1