BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3011568 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-02088
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 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: A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED NO DAMAGE TO THE CATHETER. NO KINKS OR DAMAGE WERE NOTED ALONG THE SHAFT OF THE DEVICE. A MICROSCOPIC EXAMINATION OF THE TIP AND BALLOON FOUND NO ISSUES. THE RETURNED DEVICE WAS CONNECTED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED. NO LEAK WAS NOTED. THE INFLATION DEVICE WAS SUBSEQUENTLY VERIFIED BEFORE AND AFTER USE WITH A CALIBRATED PRESSURE GAUGE (# (B)(4)). THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE. THE BALLOON INFLATED AND DEFLATED SUCCESSFULLY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. AN 80% STENOSED, UNCALCIFIED, ECCENTRIC, 25MM IN LENGTH, 2.75 MM IN DIAMETER, DE NOVO TARGET LESION WAS FOUND IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 20 X 2.0MM MAVERICK2 BALLOON CATHETER WAS SELECTED AND ADVANCED TO PREDILATE THE TARGET LESION. AT UNKNOWN NUMBER OF INFLATIONS, THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND 2 UNSPECIFIED STENTS WERE DEPLOYED IN THE DISTAL AND PROXIMAL LAD. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED ONCE AND THE "HEAD" OF THE BALLOON RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113934 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820200 15352800

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR