BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2860947 · Received December 6, 2012

    Report

    Report Number
    2134265-2012-07249
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL EXAMINATION IDENTIFIED BLOOD WITHIN THE INFLATION LUMEN WHICH IS EVIDENCE OF A DEVICE LEAK. SOLIDIFIED CONTRAST MEDIA WAS ALSO PRESENT WITHIN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE. THE BALLOON COULD NOT BE INFLATED DUE TO THE SOLIDIFIED MATERIAL PRESENT WITHIN THE INFLATION LUMEN. THE DEVICE WAS SOAKED IN WARM WATER FOR A PERIOD OF TIME TO HELP SOFTEN THE SOLID MATERIAL. A SUBSEQUENT ATTEMPT WAS MADE TO INFLATE THE BALLOON AND A LEAK WAS NOTED. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL OBSERVED THAT THE PINHOLE WAS LOCATED IN THE PROXIMAL BALLOON BODY. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE MICROSCOPICALLY EXAMINED AND THERE WERE NO ISSUES NOTED WITH THEIR PROFILES. NO OTHER DAMAGE(S) WERE NOTED TO THE BALLOON. 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, A BALLOON RUPTURE OCCURRED.THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. THIS 30MM X 2.00MM APEX MONORAIL BALLOON CATHETER WAS INFLATED TO 8ATM AND RUPTURED UPON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT FROM INSIDE THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER APEX MONORAIL BALLOON CATHETER. 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 INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. THIS 30MM X 2.00MM APEX MONORAIL BALLOON CATHETER WAS INFLATED TO 8ATM AND RUPTURED UPON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT FROM INSIDE THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER APEX MONORAIL BALLOON CATHETER. 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¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895930200 13654791

    Patients

    Seq Age Sex Outcome Treatment
    1