BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR?

    MDR report key: 3940365 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04151
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. POSITIVE PRESSURE WAS APPLIED AND A LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS CONFIRMED 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 8.0MM X 40MM, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. THE BALLOON WAS INFLATED; HOWEVER, IT RUPTURED AT 18 ATMOSPHERES ON THE THIRD INFLATION. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419797 GLADIATOR? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207080470 16884719

    Patients

    Seq Age Sex Outcome Treatment
    1