BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)

    MDR report key: 19342189 · Received May 17, 2024

    Report

    Report Number
    2135147-2024-02248
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 10, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    08717648231025
    PMA / PMN Number
    K190167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED. HOWEVER, INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED LOSS OF FLUID COLUMN WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. ADDITIONALLY, THERE WAS NO SILICONE FLUID OBSERVED AT THE SGC HEMOSTASIS VALVE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION AND THE RETURNED DEVICE ANALYSIS, THE REPORTED LOSS OF FLUID COLUMN WAS LIKELY A CASCADING EVENT OF THE OBSERVED MISSING SILICON FLUID. THE INVESTIGATION DETERMINED THE REPORTED LOSS OF FLUID COLUMN AND OBSERVED MISSING SILICONE FLUID TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXCEPTION ESCALATION AS THE COMPLAINT DESCRIPTION AND DEVICE CODE MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THEREFORE, EXCEPTION (ISSUE) 130614 AND EXCEPTION (ACTION) 136007 ARE REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE POTENTIAL ROOT CAUSE TO BE MAN. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF A STEERABLE GUIDE CATHETER (SGC), THE DEVICE WAS LEAKING WAS NOT HOLDING COLUMN. TROUBLESHOOTING WAS PERFORMED BUT WAS NOT SUCCESSFUL. THEREFORE, THE SGC WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920660 MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR) CATHETER, STEERABLE DRA ABBOTT MEDICAL 30920R1059 08717648231025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown