BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 STEERABLE GUIDING CATHETER (CE)

    MDR report key: 18896959 · Received March 13, 2024

    Report

    Report Number
    2135147-2024-01112
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 21, 2024
    Report Date
    April 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

    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 LEAK AND BROKEN FLUSH PORT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. ADDITIONALLY, THE FLUSH PORT LUER WAS NOT RETURNED. 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, THE REPORTED LEAK WAS A CASCADING EVENT OF THE REPORTED BROKEN FLUSH PORT. THE REPORTED MISSING FLUSH PORT LUER WAS DUE TO POST-PROCEDURAL HANDLING AS THE LUER WAS NOT RETURNED FOR DEVICE ANALYSIS. THE INVESTIGATION DETERMINED THE REPORTED BROKEN SGC HEMOSTASIS VALVE FLUSH PORT 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) 127621 AND EXCEPTION (ACTION) 132488 ARE REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE POTENTIAL ROOT CAUSE TO BE MOTHER NATURE IN THE FORM OF ENVIRONMENTAL STRESS CRACKING (ESC). 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 DURING PREPARATION OF A STEERABLE GUIDE CATHETER (SGC), THE FLUSH PORT WAS OBSERVED TO BE BROKEN, RESULTING IN A LEAK WHILE DE AIRING. THEREFORE, THE SGC WAS NOT USED AND REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212919 G4 STEERABLE GUIDING CATHETER (CE) CATHETER, STEERABLE DRA ABBOTT MEDICAL 31011R1086 08717648231032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown