BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3805883 · Received May 12, 2014

    Report

    Report Number
    2134265-2014-02559
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 16, 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 MF.; A VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE FOUND NO KINKS OR DAMAGE ALONG THE ENTIRE LENGTH OF THE DEVICE. THERE WAS BLOOD PRESENT IN THE BALLOON. POSITIVE PRESSURE WAS APPLIED AND LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS CONFIRMED A PINHOLE IN THE DISTAL BALLOON BODY. NO OTHER DEFECTS WERE NOTED. 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 A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS ARTERIOVENOUS FISTULA (AVF) OF THE FOREARM. A 4.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. 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 A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS ARTERIOVENOUS FISTULA (AVF) OF THE FOREARM. A 4.0 X 40, 40CM MUSTANG¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. 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
    284590 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171040440 0016692905

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MOSQUITO 5FR| INFLATION DEVICE: ENCORE26| GUIDEWIRE: RADIFOCUS035