BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1832820 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03995
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    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

    (B)(4). AS THE DEVICE HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN ADVANCED THE 2.5MM X 15MM MAVERICK 2 BALLOON CATHETER. ON THE FIRST INFLATION THE BALLOON WAS PARTIALLY INFLATED TO 12ATMS AND RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815250 0013396617

    Patients

    Seq Age Sex Outcome Treatment
    1