BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1637972 · Received March 23, 2010

    Report

    Report Number
    2134265-2010-01298
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    February 23, 2010
    Report Date
    February 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. 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 AND/OR PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURSYM PROCEDURE, A BALLOON RUPTURE OCCURRED. AFTER THE UNKNOWN STENT GRAFT WAS IMPLANTED, THE EQL/ 33X7X2X65 EQUALIZER BALLOON CATHETER WAS USED. UPON INFLATION THE BALLOON RUPTURED. THE NUMBER OF INFLATIONS IS UNKNOWN. NO PATIENT COMPLICATIONS OCCURRED. THE PATIENT STATUS WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171090 0012877932

    Patients

    Seq Age Sex Outcome Treatment
    1