BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 10634661 · Received October 6, 2020

    Report

    Report Number
    3004193842-2020-00029
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    November 9, 2018
    Report Date
    November 20, 2020
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL STUDY CHANGED FROM SCOPE I TO SCOPE II. PATIENT AGE AND GENEDER ADDED - THE PATIENT WAS AN 86-YEAR-OLD FEMALE. HOSPITAL NAME ADDED - (B)(6).

    Description of Event or Problem · 0

    EVENT DESCRIPTION: THE EVENT WAS REPORTED AS PART OF THE SCOPE II CLINICAL STUDY DATA (1 YEAR FOLLOW UP) . SCOPE II IS AN INVESTIGATOR-SPONSORED RESEARCH (ISR) CLINICAL STUDY INVOLVING THE ACURATE NEO AORTIC BIOPROSTHESIS AND THE ACURATE TF TRANSFEMORAL DELIVERY SYSTEM. BOSTON SCIENTIFIC (BSC) RECEIVED DATA IN AN ANONYMIZED FORMAT. THEREFORE, FOR MAINTAINING PATIENT ANONYMITY, ONLY LIMITED INFORMATION WAS DISCLOSED TO BSC. BSC IS UNABLE TO ACQUIRE ANY FURTHER INFORMATION, AND THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BSC. EVENT DESCRIPTION: PER CLINICAL FORM/REPORT, IT WAS REPORTED THAT: 5 DAYS POST RANDOMIZATION BLEEDING (VASCULAR ACCESS SITE / RETROPERITONEAL, BARC 3A. THE PATIENT REQUIRING TRANSFUSION OF 3 UNITS OF WHOLE BLOOD/RBC.) EVENT DATE: (B)(6) 2018. NO PROCEDURAL ANGIOGRAPHIC MEDIA WAS MADE AVAILABLE FOR REVIEW. NO FURTHER INFORMATION IS AVAILABLE ON THE EVENT.

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR IS UNABLE TO ACQUIRE ANY FURTHER INFORMATION FOR THIS COMPLAINT. FOR MAINTAINING PATIENT ANONYMITY SOME DATA SETS WERE RECEIVED IN AN ANONYMIZED FORMAT FROM THE STUDY SPONSOR, AND SITE IDENTIFICATION WAS REMOVED AS PART OF THE ANONYMIZATION PROCESS. AS OF THE (B)(6) 2020, WHEN THE COMPLAINT ANALYSIS WAS COMPLETED, NO ADDITIONAL INFORMATION WAS RECEIVED. BSC HAVE REQUESTED FURTHER INFORMATION BUT DID NOT RECEIVE ANY INFORMATION. AS SUCH IT IS NOT POSSIBLE TO CONFIRM IF THIS COMPLAINT HAS PREVIOUSLY BEEN REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS WILL BE REVIEWED, AND THE REPORT WILL BE UPDATED ACCORDINGLY IN CASE IT CHANGES THE CONCLUSIONS. THE PRODUCT WAS NOT RETURNED FOR REVIEW AT THE TIME OF THIS REPORT BEING COMPLETED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND EXAMINATION. IT WAS THEREFORE NOT POSSIBLE TO CARRY OUT ANY INSPECTION OR EXAMINATION ON THE DEVICE. THEREFORE, THE PRIMARY AS REPORTED CLASSIFICATIONS: LOTUS - PATIENT - BLEEDING CANNOT BE CONFIRMED. FOLLOWING THE INVESTIGATION CONCLUSIONS, THE COMPLAINT ANALYSED CLASSIFICATION IS ASSIGNED AS LOTUS - PRODUCT NOT RETURNED - COMPLAINT UNABLE TO CONFIRM. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE EXECUTED AS THE LOT NUMBER IS UNKNOWN. DUE TO THIS LIMITED INFORMATION PROVIDED ON THE COMPLAINT DEVICE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT POSSIBLE TO IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. ALL SHIPPED DEVICES ARE PROCESSED THROUGH FINAL ASSEMBLY, STERILISATION AND PACKAGING UNDER STRICT OPERATIONAL CONDITIONS THAT INHIBIT THE RELEASE OF NON-CONFORMING MANUFACTURED PRODUCT TO THE DISTRIBUTION CYCLE. A SHIP HISTORY FOR THIS COMPLAINT HAS BEEN REQUESTED FROM BSC. FOR CREGANNA MEDICAL CASE CM-CASE-2020-00000515 (BSC CASE 12852727) THE CUSTOMER NUMBER IS UNKNOWN AND SO A SHIP HISTORY WILL NOT BE POSSIBLE. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. THE LOTUS INTRODUCER SHEATH PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH THE USE OF THE LOTUS INTRODUCER SHEATH WHICH INCLUDE BUT ARE NOT LIMITED TO 'INJURY TO THE VASCULAR INTRODUCTION SITE'. FOLLOWING A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SET DEVICE. THERE IS NO INDICATION OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT IS DEEMED REPORTABLE. UPON ABOVE INFORMATION, ESCALATION IS REQUIRED TO QUALITY MANAGEMENT TEAM. THE PROBABLE INVESTIGATION CONCLUSION CODE ASSIGNED TO THIS COMPLAINT IS 'KNOWN INHERENT RISK OF DEVICE' DEFINED AS 'REPORTED ADVERSE EVENT KNOWN AND DOCUMENTED IN THE LABELLING (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS)'. THERE IS NO EVIDENCE OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    EVENT DESCRIPTION THE EVENT WAS REPORTED AS PART OF THE SCOPE I CLINICAL STUDY DATA (1 YEAR FOLLOW UP) . SCOPE I IS AN INVESTIGATOR-SPONSORED RESEARCH (ISR) CLINICAL STUDY INVOLVING THE ACURATE NEO AORTIC BIOPROSTHESIS AND THE ACURATE TF TRANSFEMORAL DELIVERY SYSTEM. BOSTON SCIENTIFIC (BSC) RECEIVED DATA IN AN ANONYMIZED FORMAT. THEREFORE, FOR MAINTAINING PATIENT ANONYMITY, ONLY LIMITED INFORMATION WAS DISCLOSED TO BSC. BSC IS UNABLE TO ACQUIRE ANY FURTHER INFORMATION, AND THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BSC. EVENT DESCRIPTION: PER CLINICAL FORM/REPORT, IT WAS REPORTED THAT: 5 DAYS POST RANDOMIZATION BLEEDING (VASCULAR ACCESS SITE / RETROPERITONEAL, BARC 3A. THE PATIENT REQUIRING TRANSFUSION OF 3 UNITS OF WHOLE BLOOD/RBC.) EVENT DATE: (B)(6) 2018. NO PROCEDURAL ANGIOGRAPHIC MEDIA WAS MADE AVAILABLE FOR REVIEW. NO FURTHER INFORMATION IS AVAILABLE ON THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101963 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention