BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 3030503 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01859
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    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 COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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 PROCEDURE (PCI), A BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS INDICATED DUE TO AMI. THE 90% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS UNKNOWN VESSEL. THE 2.50MM X 15MM APEX BALLOON CATHETER WAS ADVANCED INTO THE PATIENT. INFLATION WAS PERFORMED. THE BALLOON RUPTURED 4ATM. THE 2.5MM FLEXTOME BALLOON CATHETER WAS ADVANCED FOR DILATATION, THE BALLOON WAS INFLATED THREE TIMES AT 8ATMS FOR 10 SECONDS. THE BALLOON WAS REMOVED AND PHYSICIAN PERFORMED ADDITIONAL POBA AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134058 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895915250 15514769

    Patients

    Seq Age Sex Outcome Treatment
    1