BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 8042518 · Received November 6, 2018

    Report

    Report Number
    3004193842-2018-00011
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 3, 2018
    Report Date
    November 6, 2018
    Manufacturer
    CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS NOT RETURNED TO CREGANNA MEDICAL AND IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE. AS SUCH, THE REPORTED VESSEL DISSECTION CANNOT BE CONFIRMED. 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. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 389778 AND ALL OF ITS SUBCOMPONENTS WAS COMPLETED AND FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE REVIEW OF THE ROUTER AND SUBSEQUENT SUB ASSEMBLY ROUTERS DID NOT HIGHLIGHT ANY ANOMALIES. THERE WERE NO CAPAS (CORRECTIVE AND PREVENTATIVE ACTION), MRRS (MATERIAL REVIEW REPORT) OR DEVIATIONS GENERATED FOR THIS LOT, #389778 DURING THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AS OF 06TH NOVEMBER 2018 WHEN THE REVIEW WAS COMPLETED, THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER 389778, LOT-PC18-021 FOR THE AS REPORTED FAILURE LOTUS - PATIENT - VESSEL DISSECTION. THIS HAS BEEN FILED UNDER MDR REPORT# 3004193842-2018-00010. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. FOLLOWING COMPLETION OF CREGANNA MEDICAL INFORMATION REVIEW, THE COMPLAINT ANALYSED CLASSIFICATION HAS BEEN ASSIGNED AS:" LOTUS - PRODUCT NOT RETURNED - COMPLAINT UNABLE TO CONFIRM". 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 DEFINED AS '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 ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE 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: "REPORTED AS FOLLOW: "IT WAS REPORTED THAT THEY DID A LOTUS VALVE WHICH IS A RESEARCH PRODUCT AND EVERYTHING WENT FINE WITH THAT PART OF THE PROCEDURE. THEY ALSO USED LOTUS INTRODUCER SHEATH AND INSERTED INTO THE FEMORAL ARTERY. UPON TAKING THAT SHEATH OUT THEY HAD A MINOR DISSECTION IN THAT ARTERY THAT THEY NEEDED TO BALLOON. PATIENT IS FINE. IT OCCURRED WHEN THE INTRODUCER SHEATH WAS REMOVED SO THE DELIVERY SHEATH OF THE VALVE WAS NOT IN THE PATIENT ANY MORE WHEN THEY HAD THE DISSECTION THEY BALLOONED IT WAS A 7X4MM EVERCROSS BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880614 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR200 389778

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention