BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 2802774 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06460
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: AN EXAMINATION OF THE DEVICE FOUND A COMPLETE BALLOON CIRCUMFERENTIAL TEAR AT 20 MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. DIALYSIS GRAFT DECLOT PROCEDURE. THE TARGET LESION WAS LOCATED IN THE ARTERIAL GRAFT IN THE ARM. THE 6.0 X 40 MM GLADIATOR BALLOON CATHETER WAS INFLATED AT 24 ATMS AND RUPTURED CIRCUMFERENTIALLY ON THE 2ND INFLATION. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. DIALYSIS GRAFT DECLOT PROCEDURE. THE TARGET LESION WAS LOCATED IN THE ARTERIAL GRAFT IN THE ARM. THE 6.0 X 40 MM GLADIATOR BALLOON CATHETER WAS INFLATED AT 24 ATMS AND RUPTURED CIRCUMFERENTIALLY ON THE 2ND INFLATION. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207060470 15353211

    Patients

    Seq Age Sex Outcome Treatment
    1