BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3882873 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03438
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE FOUND NO KINKS OR DAMAGE ALONG THE ENTIRE LENGTH OF THE DEVICE. AN EXAMINATION OF THE BALLOON FOUND NO TEARS OR HOLES IN THE BALLOON. AS PART OF THE DEVICE ANALYSIS THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE WITH NO LEAKS NOTED. NO RESISTANCE WAS EXPERIENCE DURING INFLATION. USING THE SAME ENCORE INFLATION UNIT A VACUUM WAS PULLED AND THE BALLOON DEFLATED FULLY WITH NO RESISTANCE NOTED. THIS WAS REPEATED THREE MORE TIMES AND ON EACH OCCASION THE BALLOON INFLATED AND DEFLATED FULLY FROM ITS RATED BURST PRESSURE WITH NO RESISTANCE OR LEAKS NOTED. THE INFLATION DEVICE WAS VERIFIED AT THE RATED BURST PRESSURE BEFORE AND AFTER USE WITH A CALIBRATED PRESSURE GAUGE. IT WAS NOTED THAT THE BALLOON MAINTAINED PRESSURE WHEN INFLATED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 4.0X40MM MUSTANG BALLOON CATHETER WAS ADVANCED AND WAS INITIALLY INFLATED TO 16ATM FOR THE FIRST AND SECOND INFLATION, DURING THE THIRD INFLATION AFTER 10 SECONDS, THE BALLOON RUPTURED AT 12ATMS. THERE WERE NO KINKS PRESENT PRIOR TO USE AND NO RESISTANCE WAS FELT DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 4.0X40MM MUSTANG¿ BALLOON CATHETER WAS ADVANCED AND WAS INITIALLY INFLATED TO 16ATM FOR THE FIRST AND SECOND INFLATION, DURING THE THIRD INFLATION AFTER 10 SECONDS, THE BALLOON RUPTURED AT 12ATMS. THERE WERE NO KINKS PRESENT PRIOR TO USE AND NO RESISTANCE WAS FELT DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361079 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171040470 15301042

    Patients

    Seq Age Sex Outcome Treatment
    1