BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIATOR PTA BALLOON DILATION CATHETER

    MDR report key: 2875358 · Received December 17, 2012

    Report

    Report Number
    2134265-2012-07540
    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: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 PROCEDUE, A BALLOON RUPTURE AND DIFFIULTY REMOVING OCCURRED.THE GLADIATOR BALLOON RUPTURED CIRCUMFERENTIALLY, LEADING TO THE BALLOON "TENTS/UMBRELLAS/MUSHROOMS OUT", WITH REMOVAL OF THE SHEATH AND THE BALLOON BEING GRABBED WITH "CURVED KELLYS AND PULL IT OUT CREATING A MUCH LARGER DERMATOTOMY".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 Required Intervention