BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2020399 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00743
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K875064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE UNIT AND UNIT COMPONENTS IDENTIFIED NO ISSUES. THE DEVICE WAS FILLED WITH WATER AND INFLATED. NO AIR OR WATER LEAKS WERE NOTED. NO ISSUES WERE NOTED DURING INFLATION, HOWEVER, WHEN THE DEVICE REACHED 26 ATMS THE NEEDLE RETURNED TO 0 ATMS IMMEDIATELY. THIS OCCURRED DURING SEVERAL INFLATION ATTEMPTS. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS SHUNT. THE ENCORE 26 INFLATION DEVICE LEAKED AIR AND WATER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER; ANALYSIS OF THE ENCORE 26 INFLATION DEVICE IDENTIFIED GAUGE INACCURACIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M001151050 0013794048

    Patients

    Seq Age Sex Outcome Treatment
    1