BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2830606 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-06990
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    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

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GAUGE ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A LEFT TRANSRADIAL APPROACH. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THIS ENCORE 26 INFLATION DEVICE WAS ATTACHED TO AN UNSPECIFIED DEVICE. THE DEVICE WAS INFLATED TEN TIMES AND FOLLOWING THE TENTH INFLATION, IT WAS REPORTED THAT THE GAUGE OF THE ENCORE 26 INFLATION DEVICE WAS NOT WORKING "PROPERLY." THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 BALLOON CATHETER INFLATION DEVICE. NO PATIENT 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