BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3033703 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02248
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    November 22, 2012
    Report Date
    March 5, 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

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A PINHOLE LEAK WAS IDENTIFIED AT THE PROXIMAL MARKERBAND. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND OF THE PROXIMAL MARKERBAND, COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. 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 (PCI) A LEAK WAS NOTED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 15MM X 2.5MM MAVERICK BALLOON; HOWEVER, A LEAK IN THE BALLOON WAS NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED A PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136520 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815250 0015376940

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR