BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3940646 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04187
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A PINHOLE WAS IDENTIFIED IN THE BALLOON. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT, SUBJECTED TO POSITIVE PRESSURE AND A BALLOON PINHOLE WAS IDENTIFIED. THE PINHOLE WAS DIRECTLY ABOVE THE PROXIMAL MARKERBAND. THE DEVICE WAS DEFLATED AND A FURTHER MICROSCOPIC EXAMINATION REVEALED A SMALL VERTICAL SCRATCH MARK ON THE BALLOON MATERIAL APPROXIMATELY 0.4MM IN LENGTH. THE PROXIMAL MARKERBAND WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. NO ISSUES WERE NOTED WITH THE TIP SECTION OF THE DEVICE AND NO KINKS OR DAMAGE WAS NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT 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 FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED RIGHT PROXIMAL ARTERIA ILIACA COMMUNIS ARTERY. DURING THE FIRST INFLATION AFTER 50 SECONDS, THE 8.0X20 135CM MUSTANG BALLOON CATHETER RUPTURED AT 12ATM. THE DEVICE WAS SUCCESSFULLY REMOVED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED RIGHT PROXIMAL ARTERIA ILIACA COMMUNIS ARTERY. DURING THE FIRST INFLATION AFTER 50 SECONDS, THE 8.0X20 135CM MUSTANG BALLOON CATHETER RUPTURED AT 12ATM. THE DEVICE WAS SUCCESSFULLY REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED. THE PHYSICIAN INFLATED A 8.0X20, 135CM MUSTANG BALLOON CATHETER IN THE TARGET LESION AND IT RUPTURED AT 14ATM DURING AN UNKNOWN INFLATION ATTEMPT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419912 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171080210 0016445840

    Patients

    Seq Age Sex Outcome Treatment
    1