BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER¿

    MDR report key: 7673882 · Received July 10, 2018

    Report

    Report Number
    2134265-2018-06137
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 21, 2018
    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). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS DEVICE NOT RETURNED AS THE COMPLAINT DID NOT INCLUDE RETURNED DEVICE REVIEW AND LACKED THE OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ABDOMINAL AORTA. FOLLOWING STENT GRAFT PLACEMENT, A EQL/33/7/2/65 EQUALIZER¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517354 EQUALIZER¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171090 0021032906

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE- AMPLATZ| STENT- GORE