BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2840433 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07127
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 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

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED AT 56.3CM DISTAL TO THE STRAIN RELIEF. A MICROSCOPIC EXAMINATION OF THE BALLOON FOUND NO TEARS OR HOLES. THERE WAS A BUILD-UP OF SOLIDIFIED CONTRAST MEDIA INSIDE THE BALLOON. THE INNER SHAFT WAS KINKED AND STRETCHED INSIDE THE BALLOON. THE DEVICE WAS IMMERSED IN WARM WATER AND THE BALLOON INFLATED TO ITS RATED BURST PRESSURE WITH NO LEAKS NOTED. A VACUUM WAS PULLED AND THE BALLOON DEFLATED FULLY WITH NO RESISTANCE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS MODERATELY TORTUOUS IN THE LEFT ANTERIOR DESCENDING ARTERY. ON THE FIRST INFLATION THE APEX MONORAIL 12 MM X 2.50 MM WAS INFLATED TO SEVEN ATMOSPHERES AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS MODERATELY TORTUOUS IN THE LEFT ANTERIOR DESCENDING ARTERY. ON THE FIRST INFLATION THE APEX MONORAIL 12MM X 2.50MM WAS INFLATED TO SEVEN ATMOSPHERES AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895912250 0015142842

    Patients

    Seq Age Sex Outcome Treatment
    1