BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 7539814 · Received May 24, 2018

    Report

    Report Number
    3004193842-2018-00004
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 29, 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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SENT AS ADDITIONAL INFORMATION FROM THE DISTRIBUTOR WAS RECEIVED ON 24-MAY-2018 AS FOLLOWS: 'A SHIP HISTORY REPORT COMPLETED WITH THE CUSTOMER INFORMATION PROVIDED GENERATED NO RESULTS.' THE REMAINING INVESTIGATION SUMMARY FILED ON THE INITIAL MDR REMAINS THE SAME AS FOLLOWS; AS THE PRODUCT WAS NOT RETURNED TO CREGANNA MEDICAL FOR REVIEW, IT WAS NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE AND THEREFORE THE REPORTED VESSEL DISSECTION COULD NOT BE CONFIRMED. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. VESSEL DISSECTION IS ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE INSTRUCTIONS FOR USE. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. AS THE LOT NUMBER IS UNKNOWN, REVIEW OF THE MANUFACTURING DOCUMENTATION NOR A TREND REVIEW COULD NOT BE EXECUTED. A SHIP HISTORY REPORT COMPLETED WITH THE CUSTOMER INFORMATION PROVIDED GENERATED NO RESULTS. THERE IS NO EVIDENCE OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE ROOT CAUSE CLASSIFICATION CODE 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.' THIS COMPLAINT HAS BEEN ESCALATED TO THE QUALITY MANAGEMENT TEAM. THIS COMPLAINT HAS BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR). 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SENT AS ADDITIONAL INFORMATION FROM THE DISTRIBUTOR WAS RECEIVED ON 24-MAY-2018 AS FOLLOWS: 'A SHIP HISTORY REPORT COMPLETED WITH THE CUSTOMER INFORMATION PROVIDED GENERATED NO RESULTS.' THE INITIAL COMPLAINT DESCRIPTION WAS RECEIVED AT (B)(6) MEDICAL ON (B)(6) 2018 IS AS FOLLOWS: '"THE IMPLANT WAS DONE SUCCESSFULLY AND HAD GREAT RESULTS. THEY DID IMPLANT THE VALVE USING A LOTUS S INTRODUCER AND AT THE TIME OF LOTUS S SHEATH RETRIEVAL THEY HAD A RIGHT VASCULAR ACCESS DISSECTION. UNFORTUNATELY I DON'T HAVE THE LOT NO AND DETAILS OF THE LOTUS S INTRODUCER. THE DISSECTION WAS HANDLE WITH SUCCESS BY DR AND TEAM, PATIENT IS DOING VERY WELL. THEY DID USE A BALLOON TO STOP THE BLEEDING AND TODAY PATIENT IS DOING VERY WELL" ADDITIONAL INFORMATION WAS LATER RECEIVED STATED THAT UNFORTUNATELY, IT COULD NOT BE CONFIRMED WHETHER OR NOT THE LOTUS INTRODUCER CONTRIBUTED TO THE VESSEL DISSECTION. HOWEVER THEY STATED THAT THIS TYPE OF ISSUE COULD BE CAUSED BY THE PERCLOSE CLOSURE DEVICE.

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED TO CREGANNA MEDICAL FOR REVIEW, IT WAS NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION ON THE DEVICE AND THEREFORE THE REPORTED VESSEL DISSECTION COULD NOT BE CONFIRMED. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. VESSEL DISSECTION IS ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE INSTRUCTIONS FOR USE. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. AS THE LOT NUMBER IS UNKNOWN, REVIEW OF THE MANUFACTURING DOCUMENTATION NOR A TREND REVIEW COULD NOT BE EXECUTED. A REQUEST FOR A SHIP HISTORY TO BE COMPLETED WAS INITIATED BY CREGANNA MEDICAL, HOWEVER THE DISTRIBUTOR STATED THAT THE HOSPITAL ACCOUNT IS UNKNOWN AND THEREFORE A SHIP HISTORY COULD NOT BE COMPLETED. THERE IS NO EVIDENCE OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE ROOT CAUSE CLASSIFICATION CODE 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.' THIS COMPLAINT HAS BEEN ESCALATED TO THE QUALITY MANAGEMENT TEAM. THIS COMPLAINT HAS BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR). 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

    INITIAL COMPLAINT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL ON (B)(6) 2018 IS AS FOLLOWS: '"THE IMPLANT WAS DONE SUCCESSFULLY AND HAD GREAT RESULTS. THEY DID IMPLANT THE VALVE USING A LOTUS S INTRODUCER AND AT THE TIME OF LOTUS S SHEATH RETRIEVAL THEY HAD A RIGHT VASCULAR ACCESS DISSECTION. UNFORTUNATELY I DON'T HAVE THE LOT NO AND DETAILS OF THE LOTUS S INTRODUCER. THE DISSECTION WAS HANDLE WITH SUCCESS BY DR AND TEAM, PATIENT IS DOING VERY WELL. THEY DID USE A BALLOON TO STOP THE BLEEDING AND TODAY PATIENT IS DOING VERY WELL" ADDITIONAL INFORMATION RECEIVED STATED THAT UNFORTUNATELY, IT COULD NOT BE CONFIRMED WHETHER OR NOT THE LOTUS INTRODUCER CONTRIBUTED TO THE VESSEL DISSECTION. HOWEVER THEY STATED THAT THIS TYPE OF ISSUE COULD BE CAUSED BY THE PERCLOSE CLOSURE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382161 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR180 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention