BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER¿

    MDR report key: 5050383 · Received September 2, 2015

    Report

    Report Number
    2134265-2015-05797
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT SAMPLE WAS RETURNED FOR ANALYSIS. THE CATHETER SHAFT WAS INSPECTED FOR ANY DEFECTS BUT NONE WERE FOUND. THE BALLOON WAS INSPECTED AND FOUND TO BE BURST/RUPTURED NEAR THE DISTAL BOND (AT 1.4 CM FROM THE TIP). BOTH PROXIMAL AND DISTAL BALLOON BONDS WERE EXAMINED AND FOUND TO MEET THE REQUIRED BOND LENGTH SPECIFICATION. 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

    SAME CASE AS MDR ID: 2134265-2015-05798. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL AT THE ABDOMINAL AORTA. DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR, A NON-BSC ENDOVASCULAR GRAFT WAS DEPLOYED. SUBSEQUENTLY A 33/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED TO POST-DILATE THE GRAFT. HOWEVER, DURING THE FIRST INFLATION ABOUT 3-4 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS COMPLETED REMOVED FORM THE PATIENT. ANOTHER 33/7/2/65 EQUALIZER BALLOON CATHETER WAS SELECTED HOWEVER, DURING THE SECOND INFLATION AT 3-4 SECONDS, THE BALLOON RUPTURED. THE SECOND EQUALIZER BALLOON CATHETER WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580713 EQUALIZER¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171090 0017638851

    Patients

    Seq Age Sex Outcome Treatment
    1