BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC/ENCORE/ADVANTAGE

    MDR report key: 1521001 · Received October 30, 2009

    Report

    Report Number
    2134265-2009-06084
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    August 25, 2009
    Report Date
    October 2, 2009
    Manufacturer
    BSC TULLAMORE
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND FUNCTIONAL TESTING OF THE RETURNED DEVICE FOUND THAT THE GAUGE NEEDLE WAS SKIPPING. INFLATION DIFFICULTY WAS NOTED AS THE PLUNGER WAS DIFFICULTY TO ROTATE. HOWEVER, THE DEVICE WAS CAPABLE OF INFLATION UP TO 26 ATMS. THE DEVICE PASSED THE VACUUM, PRESSURE DUMPING AND LEAK TEST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DESIGN AS INTERFERENCE FIT BETWEEN THE LOCKNUT AND PLUNGER MAY HAVE CONTRIBUTED TO THIS COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    SAME AS MFR# 2132456-2009-06083. REPORTABLE BASED ON PRODUCT ANALYSIS COMPLETED ON (B)(6) 2009. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE NOISE WAS HEARD AND INFLATION DIFFICULTY WAS NOTED. THE LESION LOCATION AND CHARACTERISTICS ARE UNKNOWN. THE PHYSICIAN HEARD NOISE FROM THE BOSTON SCIENTIFIC/ENCORE/ADVANTAGE INFLATION DEVICE AND FELT A RESISTANCE ON THE 2ND INFLATION WHEN THE PRESSURE REACHED TO ABOUT 10 ATMS. THE PRESSURE WOULD NOT RISE ABOVE 10 ATMS. THEREFORE, THE PHYSICIAN REPLACED THE ENCORE26 INFLATION DEVICE WITH ANOTHER AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WERE NO COMPLICATIONS OR INJURIES WERE REPORTED. THE PATIENT STATUS WAS LISTED AS 'GOOD'. RETURNED PRODUCT ANALYSIS REVEALED THAT A GAUGE NEEDLE WAS SKIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC/ENCORE/ADVANTAGE MAV SYRINGE, BALLOON INFLATION MAV BSC TULLAMORE NA 2047906

    Patients

    Seq Age Sex Outcome Treatment
    1