BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3822458 · Received May 20, 2014

    Report

    Report Number
    2134265-2014-02708
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 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. A FURTHER MICROSCOPIC ANALYSIS REVEALED LONGITUDINAL TEAR IN THE MID BALLOON BODY MEASURING APPROXIMATELY 50MM IN LENGTH. THE EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THIS COMPLAINT. 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 BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 7.0MM X 40MM, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 7.0MM X 40MM, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300506 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171070470 16629625

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 5FR / TERUMO| INFLATION DEVICE: KANEKA| GUIDE WIRE: RADIFOCUS / TERUMO