BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3103284 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03027
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE 78.5CM FROM THE STRAIN RELIEF. THE HYPOTUBE WAS ALSO KINKED AT VARIOUS LOCATIONS ALONG THE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DEVICE DURING USE/HANDLING. 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 (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, INABILITY OF THE BALLOON TO DILATE IN THE LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 15MM X 1.5MM MAVERICK² BALLOON CATHETER WAS USED HOWEVER THE BALLOON COULD NOT DILATE IN THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A BREAK IN THE HYPOTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204084 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815150 0015369537

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR