BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 STEERABLE GUIDING CATHETER (CE)

    MDR report key: 19383354 · Received May 23, 2024

    Report

    Report Number
    2135147-2024-02351
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    08717648231032
    PMA / PMN Number
    K190167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 RETURNED DEVICE ANALYSIS CONFIRMED THE REPORTED LEAK/SPLASH. ADDITIONALLY, IT WAS IDENTIFIED THAT THE DILATOR WAS DIFFICULT TO INSERT, AND THE SILICONE FLUID WAS MISSING IN THE SGC HEMOSTASIS VALVE. MISSING SILICONE FLUID APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE; THEREFORE, THIS COMPLAINT IS WITHIN THE SCOPE OF EXCEPTION (ISSUE) 130614 AND EXCEPTION (ACTION) 136007 AS THE COMPLAINT DESCRIPTION AND DEVICE CODES MATCH THE SPECIFIC ISSUE DESCRIBED IN THE 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 COMPLAINTS FROM THE LOT. THE INVESTIGATION DETERMINED THE REPORTED LEAK (LOSS OF FLUID COLUMN DURING DEVICE PREPARATION) AND OBSERVED DIFFICULT TO INSERT DILATOR TO BE DUE TO THE OBSERVED MISSING SILICONE FLUID IN THE SGC HEMOSTASIS VALVE. MISSING SILICONE FLUID APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE PROBABLE 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 ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR) GRADE 4. DURING PREPARATION OF THE STEERABLE GUIDE CATHETER (SGC), THE HEMOSTASIS VALVE WAS LEAKING AND AIR WAS ENTERING CAUSING LOSS OF FLUID COLUMN. A REPLACEMENT SGC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED WITH THE ISSUE AND NO CLINICALLY SIGNIFICANT DELAY.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616564 G4 STEERABLE GUIDING CATHETER (CE) CATHETER, STEERABLE DRA ABBOTT MEDICAL 40124R1024 08717648231032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown