BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 2801886 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06392
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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).

    Additional Manufacturer Narrative · 1

    DEVICE AVAIL. FOR EVAL, RETURNED TO MFR. ON, DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT A LONGITUDINAL TEAR EXISTED IN THE BALLOON MATERIAL. THE TEAR STRETCHED FROM THE PROXIMAL MARKERBAND TO THE DISTAL MARKERBAND AND MEASURED APPROXIMATELY 41MM IN LENGTH. A MICROSCOPIC EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. 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 DURING AN ARTERIOVENOUS FISTULOGRAM PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. THE 8.0MM X 40MM GLADIATOR BALLOON CATHETER WAS ADVANCED INTO THE PATIENT. DURING THE FIRST INFLATION, THE BALLOON RUPTURED BEFORE THE NOMINAL PRESSURE WAS ACHIEVED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER GLADIATOR BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULOGRAM PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. THE 8.0MM X 40MM GLADIATOR BALLOON CATHETER WAS ADVANCED INTO THE PATIENT. DURING THE FIRST INFLATION, THE BALLOON RUPTURED BEFORE THE NOMINAL PRESSURE WAS ACHIEVED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER GLADIATOR BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207080470 15400724

    Patients

    Seq Age Sex Outcome Treatment
    1