BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3090596 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02906
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 7, 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 EVALUATED BY MFR. THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. AN EXAMINATION OF THE MIDSHAFT FOUND THAT IT WAS KINKED AT 3MM PROXIMAL TO THE EXCHANGE PORT. THE KINKING THAT WAS EVIDENT ALONG THE DEVICE IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. A VISUAL EXAMINATION OF THE BALLOON FOUND A LONGITUDINAL TEAR IN THE BALLOON MATERIAL. THE TEAR STRETCHED FROM THE PROXIMAL MARKERBAND AND EXTENDED DISTALLY ALONG THE BALLOON FOR A TOTAL LENGTH OF 13MM. 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

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON BURST OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 20MM X 2.5MM MAVERICK BALLOON CATHETER WAS USED FOR PRE-DILATATION. WHEN THE PHYSICIAN DILATED THE BALLOON, IT BURST. THE PHYSICIAN THEN USED ANOTHER 20MM X 2.5MM MAVERICK BALLOON AT 14 ATMOSPHERES, 6 TIMES AND 8 SECONDS SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192287 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820250 15330740

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR