BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 8408780 · Received March 11, 2019

    Report

    Report Number
    3004193842-2019-00003
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 12, 2019
    Report Date
    March 11, 2019
    Manufacturer
    CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
    Product Code
    DYB
    UDI-DI
    05391526210116
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 26-FEB-2019, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR; 'IT WAS REPORTED THAT THE PATIENT RECEIVED 2 UNITS OF BLOOD AND HAS BEEN ADMITTED IN THE HOSPITAL. THE PATIENT IS UNDER SEPSIS WATCH. ADDITIONAL FOLLOWUP IS BEING CONDUCTED TO OBTAIN MORE DETAILS AND WILL BE FORWARDED TO CREGANNA IF RECEIVED.' IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE FILED WITH THE FDA. THE COMPLIANT DEVICE WAS NOT RETURNED TO CREGANNA MEDICAL FOR REVIEW AT THE TIME THIS REPORT WAS COMPLETED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A FOLLOW UP REPORT WILL BE FILED WITH THE FDA. AS THE COMPLAINT DEVICE WAS NOT RETURNED TO CREGANNA MEDICAL, IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. AS SUCH, THE REPORTED ISSUE CANNOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION WAS COMPLETED. THERE WERE NO CAPAS (CORRECTIVE AND PREVENTATIVE ACTION), MRRS (MATERIAL REVIEW REPORT) OR DEVIATIONS GENERATED FOR THIS LOT, # 397364 DURING THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE IS NO EVIDENCE OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS DEVICE. AS OF 11-MARCH- 2019 WHEN THE COMPLAINT REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER "#OT", # 397364, FOR THE AS REPORTED FAILURES: PRIMARY CLASSIFICATION PATIENT - VESSEL DISSECTION. A REVIEW OF RISK MANAGEMENT DOCUMENTATION WAS COMPLETED. BASED ON THIS REVIEW AND INFORMATION AVAILABLE, IT WAS CONCLUDED THAT THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT AND THEREFORE NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION DUE TO THE REPORTED INCIDENT. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. VESSEL DISSECTION IS ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE INSTRUCTIONS FOR USE. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'ANTICIPATED PROCEDURAL COMPLICATION' WHICH IS A DESCRIPTION UTILIZED WHEN A DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE INSTRUCTIONS FOR USE, AND OR DEVICE LABELLING. VESSEL DISSECTION IS AN ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE DEVICE INSTRUCTIONS FOR USE. THIS COMPLAINT WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM. BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "IT WAS REPORTED THAT: FEMORAL ARTERY DISSECTION DURING A LOTUS EDGE IMPLANT. THE DEVICE WAS FINE IT IS JUST THAT THE PATIENT JUST HAD DISSECTION AT THE FEMORAL ARTERY WHERE THE SHEATH GOES IN TO THE PATIENT AND THEN THEY HAD TO USE A COVERED STENT TO FIX THE DISSECTION. THEY USED A VIABAHN 10MM X 4CM COVERED STENT TO ACHIEVE HEMOSTASIS. THIS HAPPENED TOWARDS THE END OF THE PROCEDURE, INSIDE THE PATIENT'S BODY. THE PATIENT IS FINE." ON 26-FEB-2019, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED; 'IT WAS REPORTED THAT THE PATIENT RECEIVED 2 UNITS OF BLOOD AND HAS BEEN ADMITTED IN THE HOSPITAL. THE PATIENT IS UNDER SEPSIS WATCH.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203294 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR200 397364 05391526210116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention