BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIATOR PTA BALLOON DILATION CATHETER

    MDR report key: 2875356 · Received December 17, 2012

    Report

    Report Number
    2134265-2012-07708
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATION BY MANUFACTURER: AS THE DEVICE HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 UNSPECIFIED ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND DETACHMENT OCCURRED. A GLADIATOR BALLOON RUPTURED ON THE INITIAL INFLATION INSIDE AN UNSPECIFIED STENT IN A RIGHT ARM FISTULA AND WAS UNABLE TO BE REMOVED COMPLETELY. AN ADDITIONAL STENT WAS PLACED TO SECURE THE BALLOON MARKERBAND IN PLACE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS REPORTED AS FINE.ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADIATOR PTA BALLOON DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other