BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 1911503 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05327
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K875064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: AN INITIAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT CARRIED OUT AS THE PRODUCT WAS NOT RETURNED TO SITE FOR INVESTIGATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY PROCEDURE THERE WAS AN INFLATION ISSUE. THE 100% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE ENCORE INFLATION DEVICE WAS BEING USED AND THE PRESSURE WOULD NOT EXCEED MORE THEN FOUR ATMOSPHERES. THE THREE WAY STOPCOCK WAS EXCHANGED AND THE CONNECTION WAS CHECKED AND WAS STILL UNABLE TO INCREASE THE PRESSURE. 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
    1 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M001151050 0013725029

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: TRANSEND ES| BALLON CATHETER: STERLING ES 2.0-40| INTRODUCER SHEATH: 6FR 45CM MEDIKIT