BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 7406093 · Received April 9, 2018

    Report

    Report Number
    3004193842-2018-00003
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 9, 2018
    Manufacturer
    CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
    Product Code
    DYB
    UDI-DI
    05391526210109
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLIANT DEVICE HAS NOT BEEN RETURNED TO CREGANNA MEDICAL TO DATE, THEREFORE A TECHNICAL ANALYSIS COULD NOT BE COMPLETED. SHOULD THE DEVICE BE RECEIVED AT CREGANNA MEDICAL IN THE FUTURE, THE INVESTIGATION REPORT WILL BE UPDATED AND A SUPPLEMENTAL MDR CONTAINING THE UPDATED INFORMATION WILL BE FILED WITH THE FDA. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE REPORTED LOT# 426577 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 REVIEW WAS COMPLETED FOR LOT# 426577 TO DETERMINE IF OTHER COMPLAINTS HAD BEEN REPORTED AGAINST THIS LOT WITH A SIMILAR FAILURE MODE. 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. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THROMBOSIS IS CONSIDERED AS AN ANTICIPATED PROCEDURAL COMPLICATION AS NOTED WITHIN THE INSTRUCTIONS FOR USE. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. 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. 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 WAS RECEIVED AT CREGANNA MEDICAL ON 12-MAR-2018 AS FOLLOWS: 'PROBLEM DURING THE INSERTION OF THE TRANSGLIDE INTRODUCER SHEATH (B)(4) BECAUSE THE DILATOR DIDN'T ADVANCE IN THE MESH SO A SECOND ATTEMPT WITH LIS-S (426577) WAS SUCCESSFULLY COMPLETED. AT THIS POINT THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT AFTER THE INTRODUCER REMOVAL A THROMBUS WAS NOTICED AT LEVEL OF EXTERNAL ILIAC THAT WAS REMOVED SURGICALLY.' ADDITIONAL INFORMATION WAS ON THE COMPLAINT NOTIFICATION FORM AS FOLLOWS; 'INDICATION OF PROCEDURE :AORTIC VALVE STENOSIS. WAS IVUS USED? NO. WAS A GENERATOR INVOLVED? NO. WAS THE PROBLEM ASSOCIATED WITH LABELED USE? YES. ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: SURGERY: VASCULAR SURGERY INTERVENTION TO REMOVE THE THROMBUS. EVENT RESOLVED? YES. PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE: RELATED. PLEASE CHECK ALL THOSE THAT CAN BE FORWARDED TO BSC: PROCEDURE NOTES.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251606 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR180 426577 05391526210109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention