BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 2901994 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08255
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE BALLOON WAS PARTIALLY INFLATED WITH LIQUID. IT WAS POSSIBLE TO INFLATE THE BALLOON TO ITS RATED BURST PRESSURE WITHOUT ANY ISSUE NOTED. A VACUUM WAS PULLED IN AN ATTEMPT TO DEFLATE THE BALLOON. IT WAS NOTED THAT THE BALLOON DID DEFLATE HOWEVER IT TOOK LONGER THAN SPECIFICATION. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ANOMALIES. IT WAS POSSIBLE TO INSERT A 0.035 INCH GUIDEWIRE THROUGH THE GUIDEWIRE LUMEN WITHOUT ANY ISSUE. THE SHAFT WAS DISSECTED AT THE LAPWELD AREA APPROXIMATELY 700MM DISTAL TO THE STRAIN RELIEF. EXAMINATION OF THE INFLATION LUMEN NOTED THAT THE EXPECTED CRESCENT SHAPE WAS IN THE INCORRECT ORIENTATION, INDICATING THAT THE CRESCENT OR "SMILE" MANDREL WAS PLACED IN THE INCORRECT ORIENTATION IN THE BALLOON LUMEN DURING PROCESSING. DURING THE WELD PROCESS THIS WOULD HAVE DISRUPTED THE FLOW OF MATERIAL AT THE ENTRANCE OF THE BALLOON LUMEN WITH THE FORMATION OF A THIN LAYER OR FLAP OF MATERIAL. DURING DEFLATION WITH LIQUID THIS FLAP COLLAPSES CREATING A BLOCKAGE AT THE ENTRANCE OF THE BALLOON LUMEN AND A SLOWER DEFLATION TIME. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS MANUFACTURING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FISTULOGRAM PROCEDURE, DEFLATION ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ARM FISTULA. USING 50/50 CONTRAST SOLUTION A 8.0 X 40, 75 CM GLADIATOR BALLOON CATHETER WAS INFLATED USING A 3 CC SYRINGE TO 20 ATMS/30 SECONDS. DURING ATTEMPT TO DEFLATE, THE BALLOON WOULD NOT DEFLATE. HOWEVER, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE GLADIATOR BALLOON CATHETER WAS REMOVED WITH A SMALL AMOUNT OF CONTRAST REMAINING IN THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE VESSEL WAS MODERATELY TORTUOUS. THE GLADIATOR BALLOON CATHETER WAS ADVANCED TO POST DILATE THE TARGET LESION. MULTIPLE INFLATIONS WERE PERFORMED. AFTER SEVERAL MINUTES THE BALLOON WOULD NOT DEFLATE. THE BALLOON CATHETER WAS REMOVED INTACT, PARTIALLY INFLATED WITH THE INTRODUCER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8861 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207080470 15588547

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR