BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER¿

    MDR report key: 6725406 · Received July 19, 2017

    Report

    Report Number
    2134265-2017-07202
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    July 3, 2017
    Report Date
    July 3, 2017
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL ILIAC ARTERY. AN EQL/27/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506512 EQUALIZER¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171070 0020093410

    Patients

    Seq Age Sex Outcome Treatment
    1