BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2904393 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08230
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE UNIT WAS VISUALLY INSPECTED FOR ANY DAMAGE OR DEFECT. IT WAS NOTED THAT THE GAUGE NEEDLE WAS STUCK AT 4ATM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, GAUGE ISSUES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25X15 NON-BSC BALLOON CATHETER WAS ATTACHED TO AN ENCORE 26 INFLATION DEVICE AND INFLATED TO 15 ATMS. WHEN THE PHYSICIAN TRIED TO DEFLATE THE BALLOON, THE GAUGE OF THE INFLATION DEVICE WAS "NOT ABLE TO DECREASE AT 4ATM." THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, GAUGE ISSUES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25X15 NON-BSC BALLOON CATHETER WAS ATTACHED TO AN ENCORE 26 INFLATION DEVICE AND INFLATED TO 15 ATMS. WHEN THE PHYSICIAN TRIED TO DEFLATE THE BALLOON, THE GAUGE OF THE INFLATION DEVICE WAS "NOT ABLE TO DECREASE AT 4ATM". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11435 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904526011 0015548606

    Patients

    Seq Age Sex Outcome Treatment
    1 15X2.25MM HIRYU BALLOON CATHETER