BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2070903 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01345
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL EXAMINATION REVEALED NO DEFECTS WITH THE UNIT OR UNIT COMPONENTS. THE UNIT PASSED ALL FUNCTIONALLY TESTING. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN INACCURATE READING ON THE PRESSURE GAUGE OCCURRED. THE PHYSICIAN WAS USING AN ENCORE 26 INFLATION DEVICE TO PRESSURIZE AN UNSPECIFIED BALLOON AND DURING THE PRESSURIZING OF THE BALLOON THE PRESSURE GAUGED JUMPED FROM 12 TO 18ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION UNIT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN INACCURATE READING ON THE PRESSURE GAUGE OCCURRED. THE PHYSICIAN WAS USING AN ENCORE 26 INFLATION DEVICE TO PRESSURIZE AN UNSPECIFIED BALLOON AND DURING THE PRESSURIZING OF THE BALLOON THE PRESSURE GAUGED JUMPED FROM 12 TO 18ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION UNIT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904526011

    Patients

    Seq Age Sex Outcome Treatment
    1