BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3891451 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03557
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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). 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. POSITIVE PRESSURE WAS APPLIED AND A LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS FOUND A PINHOLE IN THE MID BALLOON BODY. 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 THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE 6.0MM X 100MM, 135CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO PREDILATE THE LESION. THE BALLOON WAS INFLATED FOR 15 SECONDS, HOWEVER, IT RUPTURED AT 10 ATMOSPHERES ON THE FIRST INFLATION. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE DEVICE WAS EXCHANGED TO A 5-40/5.3/135 MUSTANG¿ BALLOON CATHETER. THEN A 6MM X 100MM NON BSC STENT WAS DEPLOYED THEN POST DILATION WAS DONE USING THE SAME 5-40/5.3/135 MUSTANG¿ BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PROBLEM WAS FOUND ON THE LESION BASED ON ANGIOGRAPHY. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369021 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171061010 16714214

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CHEVALIER 0.014| GUIDING CATHETER: DESTINATION 6F