BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1951362 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05817
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    September 28, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED PRODUCT REVEALED THE DEVICE WAS RECEIVED IN 2 PIECES. THE PROXIMAL END MEASURED APPROXIMATELY 26CM TO THE BREAKING POINT. THE DISTAL END MEASURED APPROXIMATELY 123.5CM TO DISTAL TIP. CONTRAST WAS VISIBLE IN THE BALLOON WALL. MICROSCOPIC INSPECTION OF THE DEVICE REVEALED NO OTHER DAMAGE. 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)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. DURING INITIAL ADVANCEMENT OF THE 20MM X 2.0MM MAVERICK 2 BALLOON, A SHAFT BREAK OCCURRED APPROXIMATELY 4" FROM THE HUB, WHICH IS AT A PORTION UNLIKELY TO ENTER THE PATIENT. THE DEVICE WAS EXCHANGED FOR ANOTHER OF THE SAME AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER, DEVICE ANALYSIS REVEALED THE SHAFT BREAK WAS LOCATED ON A PORTION OF THE DEVICE THAT MAY ENTER THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892820200 13573973

    Patients

    Seq Age Sex Outcome Treatment
    1