BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 3013432 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01613
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL, IDENTIFIED A RADIAL TEAR IN THE BALLOON. THE TEAR WAS LOCATED AT APPROXIMATELY 11 MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE TEAR WAS NOT A COMPLETE CIRCUMFERENTIAL BUT IT DID COVER APPROXIMATELY 70% OF THE CIRCUMFERENCE OF THE BALLOON. AN EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. A NON-BSC 6F 035IN.12 X 40MM X 80CM STENT WAS PLACED IN THE VENOUS ANASTOMOSIS OF THE LEFT BRACHIAL VEIN GRAFT. THE 10 X 40MM X 75CM GLADIATOR OTW 6F BALLOON CATHETER WAS INFLATED THROUGHOUT THE STENT. ANTERIOR TO THE STENT THE BALLOON WAS INFLATED AT 12 ATMS AND BURST. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. A NON-BSC 6F 035IN.12 X 40MM X 80CM STENT WAS PLACED IN THE VENOUS ANASTOMOSIS OF THE LEFT BRACHIAL VEIN GRAFT. THE 10 X 40MM X 75CM GLADIATOR OTW 6F BALLOON CATHETER WAS INFLATED THROUGHOUT THE STENT. ANTERIOR TO THE STENT THE BALLOON WAS INFLATED AT 12 ATMS AND BURST. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114871 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207100470 15740313

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR BILIARY PROTEGE GPS: STENT