BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 10727380 · Received October 23, 2020

    Report

    Report Number
    3004193842-2020-00030
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    May 14, 2018
    Report Date
    October 23, 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 · 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. CREGANNA MEDICAL COULD NOT OBTAIN ANY FURTHER INFORMATION ON THE COMPLAINT IN RELATION TO AN INTERVENTION TAKEN. IN THIS INSTANCE, CREGANNA MEDICAL WILL ERR ON THE SIDE OF CAUTION, AND MAKE THIS COMPLAINT A REPORTABLE INCIDENT IN THE UNITED STATES AS PER MEDICAL DEVICE REPORTING REGULATION CFR 21 PART 803. UNITED STATES (FDA): MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF, NOV 2016 "4.11.3; YES, FDA CONSIDERS AN EVENT THAT OCCURS IN A FOREIGN COUNTRY REPORTABLE UNDER THE MDR REGULATION IF IT INVOLVES A DEVICE THAT HAS BEEN CLEARED OR APPROVED IN THE US - OR A DEVICE SIMILAR TO A DEVICE MARKETED BY THE MANUFACTURER THAT HAS BEEN CLEARED OR APPROVED IN THE US - AND IS ALSO LAWFULLY MARKETED IN A FOREIGN COUNTRY." AS OF THE 23-OCT-2020, WHEN THE COMPLAINT ANALYSIS WAS COMPLETED, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED; THE HOSPITAL DETAILS AND THE PATIENT AGE AND GENDER ((B)(6)-YEAR-OLD FEMALE). 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, VESSEL DISSECTION AND SECONDARY AS REPORTED CLASSIFICATION OF 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 (B)(4), 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 PRIMARY AS REPORTED CLASSIFICATIONS: LOTUS; PATIENT, VESSEL DISSECTION AND SECONDARY AS REPORTED CLASSIFICATION OF 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. BASED ON THE INVESTIGATION CONDUCTED AND THE REVIEW OF THE RETURNED DEVICE THE PRIMARY AS REPORTED CLASSIFICATIONS: LOTUS; PATIENT - VESSEL DISSECTION AND SECONDARY AS REPORTED CLASSIFICATION OF LOTUS - PATIENT - BLEEDING CANNOT BE CONFIRMED. 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. A REVIEW OF THE CASE WAS COMPLETED BY CREGANNA MEDICAL CLINICIAN "THERE IS VERY LIMITED INFORMATION IS PROVIDED. IT APPEARS THAT THE LOTUS INTRODUCER SHEATH WAS USED AS THE ONLY ACCESS DEVICE BUT NO INFORMATION CONCERNING VESSEL SIZE, TORTUOSITY OR DISEASE IS PROVIDED. THERE IS ALSO NO INFORMATION PROVIDED AS TO WHETHER AN INTERVENTION WAS REQUIRED TO ADDRESS THE FINDING. VESSEL DISSECTION AND BLEEDING ARE KNOWN COMPLICATIONS OF THIS PROCEDURE AND ARE NOT SPECIFIC TO THE INTRODUCER UTILIZED. CONSISTENT WITH PREVIOUS REVIEWS, THIS IS MOST LIKELY RELATED TO PATIENT FACTORS AND NOT RELATED SPECIFICALLY TO THE LOTUS SHEATH. THE PROBABLE INVESTIGATION CONCLUSION CODE ASSIGNED TO THIS COMPLAINT IS "KNOWN INHERENT RISK OF DEVICE". THE DEFINITION OF KNOWN INHERENT RISK OF DEVICE IS: "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

    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 ACCURATE NEO AORTIC BIOPROSTHESIS AND THE ACCURATE 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: EVENT DESCRIPTION: PER CLINICAL FORM/REPORT, IT WAS REPORTED THAT, SCOPE II CLINICAL LOTUS INTRODUCER ACCESS VESSEL COMPLICATION, DISSECTION, BLEEDING. MAIN ACCESS: RIGHT FEMORAL 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
    1195225 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention