BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 7641018 · Received June 27, 2018

    Report

    Report Number
    3004193842-2018-00005
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    May 30, 2018
    Report Date
    July 10, 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
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING FILED TO GIVE THE UDI INFORMATION OF THE COMPLAINT DEVICE AS THIS WAS NOT INCLUDED WITH THE INITIAL REPORT. ALL OTHER INFORMATION ON THIS REPORT REMAINS THE SAME AS WAS FILED ON THE INITIAL MDR AS FOLLOWS; THE COMPLAINT PRODUCT WAS NOT RETURNED TO CREGANNA MEDICAL FOR REVIEW. AS THE DEVICE WAS NOT AVAILABLE, IT WAS NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. SHOULD THE DEVICE BE RECEIVED AT CREGANNA MEDICAL IN THE FUTURE, THE INVESTIGATION REPORT WILL BE UPDATED AND A FOLLOW UP MDR CONTAINING THE UPDATED INFORMATION WILL BE FILED WITH THE FDA A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS CONDUCTED. BASED ON THE REVIEW AND INFORMATION AVAILABLE, NO UPDATES TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH DEVICE WERE REQUIRED. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 453080 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. A SIMILAR COMPLAINT TREND REVIEW WAS COMPLETED FOR LOT# 453080 TO DETERMINE IF OTHER COMPLAINTS HAD BEEN REPORTED AGAINST THIS LOT WITH THE SAME AS REPORTED CLASSIFICATION AND COMPLAINTS WERE IDENTIFIED. NO OTHER DEVICE COMPLAINTS FROM THIS LOT WERE REPORTED WITH THE SAME REPORTED FAILURE MODE. A SHIP HISTORY WAS NOT REQUIRED TO BE PERFORMED AT THIS TIME AS THE BATCH NUMBER OF THE COMPLAINT DEVICE IS KNOWN. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. VESSEL DISSECTION IS NOTED WITHIN THE LOTUS DEVICE INSTRUCTIONS FOR USE AS AN ANTICIPATED PROCEDURAL COMPLICATION.. THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'ANTICIPATED PROCEDURAL COMPLICATION.' THE DEFINITION OF ANTICIPATED PROCEDURAL COMPLICATION IS 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 ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE LOTUS 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 · 0

    THIS FOLLOW UP REPORT IS BEING FILED TO GIVE THE UDI INFORMATION OF THE COMPLAINT DEVICE AS THIS WAS NOT INCLUDED WITH THE INITIAL REPORT. ALL OTHER INFORMATION ON THIS REPORT REMAINS THE SAME AS WAS FILED ON THE INITIAL MDR. INITIAL COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL ON 01-JUN-2018 IS AS FOLLOWS: 'AT THE END OF THE PLACEMENT OF THE AORTIC VALVE AND REMOVING THE LOTUS ACCESS SHEATH, IT WAS OBSERVED THAT A DISSECTION HAD OCCURRED IN THE LEFT FEMORAL AND THE PHYSICIAN PROCEEDED TO PLACING A STENT IN THE FEMORAL WITH WHICH HE COULD RESOLVE THE COMPLICATION.' ADDITIONAL INFORMATION RECEIVED WAS AS FOLLOWS: 'THE PHYSICIAN BELIEVED THAT THE CAUSE WAS THE LIS-S BECAUSE THE PATIENT HAS VERY CALCIFIED FEMORAL ARTERY'.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS NOT RETURNED TO CREGANNA MEDICAL FOR REVIEW. AS THE DEVICE WAS NOT AVAILABLE, IT WAS NOT POSSIBLE TO CARRY OUT ANY DIMENSIONAL, FUNCTIONAL, VISUAL OR MICROSCOPIC EXAMINATION AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. SHOULD THE DEVICE BE RECEIVED AT CREGANNA MEDICAL IN THE FUTURE, THE INVESTIGATION REPORT WILL BE UPDATED AND A FOLLOW UP MDR CONTAINING THE UPDATED INFORMATION WILL BE FILED WITH THE FDA A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS CONDUCTED. BASED ON THE REVIEW AND INFORMATION AVAILABLE, NO UPDATES TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH DEVICE WERE REQUIRED. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 453080 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. A SIMILAR COMPLAINT TREND REVIEW WAS COMPLETED FOR LOT# 453080 TO DETERMINE IF OTHER COMPLAINTS HAD BEEN REPORTED AGAINST THIS LOT WITH THE SAME AS REPORTED CLASSIFICATION AND COMPLAINTS WERE IDENTIFIED. NO OTHER DEVICE COMPLAINTS FROM THIS LOT WERE REPORTED WITH THE SAME REPORTED FAILURE MODE. A SHIP HISTORY WAS NOT REQUIRED TO BE PERFORMED AT THIS TIME AS THE BATCH NUMBER OF THE COMPLAINT DEVICE IS KNOWN. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. VESSEL DISSECTION IS NOTED WITHIN THE LOTUS DEVICE INSTRUCTIONS FOR USE AS AN ANTICIPATED PROCEDURAL COMPLICATION. THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'ANTICIPATED PROCEDURAL COMPLICATION'. THE DEFINITION OF ANTICIPATED PROCEDURAL COMPLICATION IS 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 ANTICIPATED PROCEDURAL COMPLICATION AND ARE KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE LOTUS 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

    INITIAL COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL ON (B)(6) 2018 IS AS FOLLOWS: 'AT THE END OF THE PLACEMENT OF THE AORTIC VALVE AND REMOVING THE LOTUS ACCESS SHEATH, IT WAS OBSERVED THAT A DISSECTION HAD OCCURRED IN THE LEFT FEMORAL AND THE PHYSICIAN PROCEEDED TO PLACING A STENT IN THE FEMORAL WITH WHICH HE COULD RESOLVE THE COMPLICATION'. ADDITIONAL INFORMATION RECEIVED WAS AS FOLLOWS: 'THE PHYSICIAN BELIEVED THAT THE CAUSE WAS THE LIS-S BECAUSE THE PATIENT HAS VERY CALCIFIED FEMORAL ARTERY'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484196 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR180 453080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention