BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2152966 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02556
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE MAVERICK 2 MONORAIL (MR) WAS RECEIVED FOR PRODUCT ANALYSIS. THERE WAS CONTRAST IN THE LUMEN AND BALLOON. INSPECTION OF THE BALLOON REVEALED A PINHOLE IN THE BALLOON MATERIAL 8MM FROM DISTAL TIP. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, DIFFICULTY CROSSING THE LESION OCCURRED. THE 92% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX (CX). DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CROSS THE LESION WITH A 2.5X20MM MAVERICK 2 MONORAIL BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED PINHOLE IN THE BALLOON.

    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 H7493892820250 13724761

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR