BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 2246270 · Received September 13, 2011

    Report

    Report Number
    2134265-2011-03920
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 19, 2011
    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)(6). (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS AORTA ABDOMINALIS. THE EQL/20/7/2/65 BALLOON WAS BEING USED TO PRE DILATE THE LESION PRIOR TO IMPLANTING A STENT GRAFT. ON THE FIRST INFLATION, THE BALLOON RUPTURED BELOW 4.8CC. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THEN PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171050 14157814

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: AMPLATZ| STENT: EXCLUDER| INTRODUCER SHEATH: MEDIKIT