BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)

    MDR report key: 18614512 · Received January 31, 2024

    Report

    Report Number
    2135147-2024-00418
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 31, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    08717648231025
    PMA / PMN Number
    K190167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, BASED ON THE REPORTED INFORMATION, EXCEPTION (ISSUE) 127621 AND EXCEPTION (ACTION) 132488 ARE REFERENCED AS THIS COMPLAINT IS WITHIN THE SCOPE OF THIS EXCEPTION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE BROKEN FLUSH PORT TO BE RELATED TO A POTENTIAL PRODUCT ISSUE. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP CONFIRMED THE ISSUE NOT TO BE RELATED TO THE MANUFACTURE, DESIGN OR LABELING OF THE PRODUCT; HOWEVER, A POTENTIAL ROOT CAUSE RELATED TO ENVIRONMENTAL STRESS CRACKING (ESC) WAS DETERMINED. ADDITIONALLY, IT WAS CONFIRMED THAT THE CALCULATED OCCURRENCE RISK LEVEL IS WITHIN THE EXPECTED RATE PER THE RISK ASSESSMENT. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR). DURING PREPARATION STEPS FOR FLUSHING THE DEVICE PER IFU WERE PERFORMED, THE FLUSH PORT ON THE STEERABLE GUIDE CATHETER (SGC) HEMOSTASIS VALVE BROKE DURING FLUSHING. THE DEVICE NEVER CONTACTED THE PATIENT. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490936 MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR) CATHETER, STEERABLE DRA ABBOTT MEDICAL 31010R1070 08717648231025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown