BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2211953 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03292
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 19, 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

    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 PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, FOREIGN MATTER WAS FOUND. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. WHEN THE PHYSICIAN WAS OPENING THE PACKAGE OF AN ENCORE 26 SINGLE INFLATION DEVICE A 2 TO 3 CM HAIR WAS FOUND INSIDE THE TRAY AFTER THE SEAL BARRIER WAS REMOVED. THERE WAS NO DAMAGE FOUND TO THE SHIPPING CONTAINER. THIS OCCURRED OUTSIDE OF THE BODY WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IT GOOD.

    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 14256875

    Patients

    Seq Age Sex Outcome Treatment
    1