BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 7185483 · Received January 12, 2018

    Report

    Report Number
    3004193842-2017-00025
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    October 2, 2017
    Report Date
    February 5, 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP MDR IS BEING SENT DUE TO RECEIVING THE FOLLOWING ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 24-JAN-2018; THEY RAN THE SHIP HISTORY REPORT WITH THE AVAILABLE CUSTOMER NUMBER. THE UPN AND BATCH DETAILS WERE UNKNOWN. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. ADDITIONAL INFORMATION WAS REQUESTED TO CONFIRM IF THE REPORTED PATIENT BLEEDING, HEMATOMA AND STENT PLACEMENT WAS DIRECTLY OR INDIRECTLY CAUSED BY THE LOTUS INTRODUCER SHEATH, HOWEVER NO FURTHER INFORMATION HAS BEEN RECEIVED AT CREGANNA MEDICAL TO DATE. SHOULD FURTHER INFORMATION IN RELATION TO THE COMPLAINT EVENT BE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MDR CONTAINING THE ADDITIONAL INFORMATION WILL BE FILED. AS THE LOT NUMBER OF THE REPORTED COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE MANUFACTURING DOCUMENTATION AND SIMILAR TREND REVIEW COULD NOT BE COMPLETED. A SHIP HISTORY OF LOTUS INTRODUCER DEVICES SOLD TO THE USER FACILITY HAS BEEN REQUESTED FROM THE DISTRIBUTOR. THIS INFORMATION HAS NOT BEEN RECEIVED AT CREGANNA MEDICAL TO DATE. SHOULD THE SHIP HISTORY OR ADDITIONAL INFORMATION BE RECEIVED IN THE FUTURE, THE INVESTIGATION REPORT WILL BE UPDATED AND A SUPPLEMENTAL MDR CONTAINING THE ADDITIONAL INFORMATION WILL BE FILED. 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 DEVICE WAS NOT RETURNED TO CREGANNA MEDICAL THEREFORE A TECHNICAL ANALYSIS COULD NOT BE COMPLETED. 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 TO STATE A POTENTIAL PROCESSING OR DESIGN FAILURE IS ASSOCIATED WITH THE COMPLAINT EVENT. THIS COMPLAINT WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM. THEREFORE THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'UNDETERMINABLE. THE DEFINITION OF 'UNDETERMINABLE' IS: 'REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE.' BASED ON THE CURRENT 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

    INITIAL COMPLAINT DESCRIPTION RECEIVED IS AS FOLLOWS: "THE (B)(6) MALE SUBJECT WAS CONSENTED INTO THE STUDY ON (B)(6) 2017 AND UNDERWENT TAVI ON (B)(6) 2017. A LOTUS SHEATH (NOTED TO BE SIZE 11, LOT/SERIAL NUMBERS ARE NOT COLLECTED FOR SHEATHS) WAS PLACED FOLLOWED BY PRE-IMPLANT VALVULOPLASTY WITH A 25MM BALLOON. A LARGE ACURATE NEO AS WAS IMPLANTED WITH ZERO POST-PROCEDURE GRADIENT. ON (B)(6) 2017, THE SUBJECT HAD BLEEDING FROM THE RIGHT GROIN. A FLUENCY STENT WAS PLACED IN THE RIGHT FEMORAL ARTERY. HEMATOMA WAS NOTED ON BOTH SIDES. THE MODERATE AE WAS RESOLVED WITHOUT SEQUELAE (RESOLVED DATE IS BLANK AT THIS TIME, QUERY PENDING). RELATIONSHIP TO DEVICE: UNRELATED RELATIONSHIP TO PROCEDURE: CAUSAL"

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED TO CONFIRM IF THE REPORTED PATIENT BLEEDING, HEMATOMA AND STENT PLACEMENT WAS DIRECTLY OR INDIRECTLY CAUSED BY THE LOTUS INTRODUCER SHEATH, HOWEVER NO FURTHER INFORMATION HAS BEEN RECEIVED AT CREGANNA MEDICAL TO DATE. SHOULD FURTHER INFORMATION IN RELATION TO THE COMPLAINT EVENT BE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MDR CONTAINING THE ADDITIONAL INFORMATION WILL BE FILED. AS THE LOT NUMBER OF THE REPORTED COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE MANUFACTURING DOCUMENTATION AND SIMILAR TREND REVIEW COULD NOT BE COMPLETED. A SHIP HISTORY OF LOTUS INTRODUCER DEVICES SOLD TO THE USER FACILITY HAS BEEN REQUESTED FROM THE DISTRIBUTOR. THIS INFORMATION HAS NOT BEEN RECEIVED AT CREGANNA MEDICAL TO DATE. SHOULD THE SHIP HISTORY OR ADDITIONAL INFORMATION BE RECEIVED IN THE FUTURE, THE INVESTIGATION REPORT WILL BE UPDATED AND A SUPPLEMENTAL MDR CONTAINING THE ADDITIONAL INFORMATION WILL BE FILED. 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 DEVICE WAS NOT RETURNED TO CREGANNA MEDICAL THEREFORE A TECHNICAL ANALYSIS COULD NOT BE COMPLETED. 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 TO STATE A POTENTIAL PROCESSING OR DESIGN FAILURE IS ASSOCIATED WITH THE COMPLAINT EVENT. THIS COMPLAINT WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM. THEREFORE THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'UNDETERMINABLE. THE DEFINITION OF 'UNDETERMINABLE' IS: 'REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE.' BASED ON THE CURRENT 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 IS AS FOLLOWS: "THE (B)(6) MALE SUBJECT WAS CONSENTED INTO THE STUDY ON (B)(6) 2017 AND UNDERWENT TAVI ON (B)(6) 2017. A LOTUS SHEATH (NOTED TO BE SIZE 11, LOT/SERIAL NUMBERS ARE NOT COLLECTED FOR SHEATHS) WAS PLACED FOLLOWED BY PRE-IMPLANT VALVULOPLASTY WITH A 25 MM BALLOON. A LARGE ACURATE NEO AS WAS IMPLANTED WITH ZERO POST-PROCEDURE GRADIENT. ON (B)(6) 2017, THE SUBJECT HAD BLEEDING FROM THE RIGHT GROIN. A FLUENCY STENT WAS PLACED IN THE RIGHT FEMORAL ARTERY. HEMATOMA WAS NOTED ON BOTH SIDES. THE MODERATE AE WAS RESOLVED WITHOUT SEQUELAE (RESOLVED DATE IS BLANK AT THIS TIME, QUERY PENDING). RELATIONSHIP TO DEVICE: UNRELATED. RELATIONSHIP TO PROCEDURE: CAUSAL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31549 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