BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH OVER-THE-WIRE

    MDR report key: 1860589 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04438
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. 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 AND/OR PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOTIC, DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN PERFORMED A DILATION WITH AN UNSPECIFIED DEVICE AND THEN ADVANCED A 1.5X8MM APEX PUSH BALLOON TO THE LESION. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, BUT THE DEVICE WAS ABLE TO CROSS THE LESION. ON THE FIRST INFLATION THE BALLOON WAS INFLATED TO 4ATMS AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A 2.5X15MM APEX BALLOON AND THREE PROMUS STENTS (2.5X28MM, 3.0X28MM AND 3.5X28MM). NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH OVER-THE-WIRE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493896008150 13628670

    Patients

    Seq Age Sex Outcome Treatment
    1 8F TERUMO INTRODUCER SHEATH| ABBOTT 20/30 INFLATION UNIT| 3G MIRACLE GUIDE WIRE| 8F LAUNCHER AL 1 SH GUIDE CATHETER