BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX FLEX MONORAIL

    MDR report key: 1852564 · Received October 4, 2010

    Report

    Report Number
    2134265-2010-04462
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 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): 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 DRUG ELUTING STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOTIC, DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 1.5X8MM APEX FLEX BALLOON TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO 6ATMS. ON THE SECOND INFLATION THE BALLOON WAS INFLATED TO 10ATMS FOR FIVE SECONDS AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A 3.0X16MM PROMUS STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX FLEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895908150 13208219

    Patients

    Seq Age Sex Outcome Treatment
    1 6F TERUMO INTRODUCER SHEATH| RUNTHROUGH GUIDE WIRE| MEDTRONIC INFLATION UNIT| BRITE TIP AL1 GUIDE CATHETER