BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1936229 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05576
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL FOUND A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR STRETCHED FROM THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND AND EXTENDED DISTALLY FOR A TOTAL LENGTH OF 5MM. A MICROSCOPIC EXAMINATION OF THE MARKERBANDS AND BALLOON MATERIAL COULD NOT IDENTIFY ANY ANOMALIES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. 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 INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25 X 20MM APEX MONORAIL BALLOON CATHETER WAS INFLATED ONCE TO 8 ATMS. DURING THE SECOND INFLATION AT 10 ATMS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25 X 20MM APEX MONORAIL BALLOON CATHETER WAS INFLATED ONCE TO 8 ATMS. DURING THE SECOND INFLATION AT 10 ATMS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895920220 13439100

    Patients

    Seq Age Sex Outcome Treatment
    1