BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX?

    MDR report key: 3894513 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03652
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 1, 2014
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. 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 A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH RETROGRADE APPROACH. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00MM X 15MM APEX¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION USING REVERSE CART TECHNIQUE. DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERES. THEY SUSPECTED THAT THE ISSUE OCCURRED DUE TO THE CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372081 APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915400 15289368

    Patients

    Seq Age Sex Outcome Treatment
    1