BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 7177960 · Received January 10, 2018

    Report

    Report Number
    3004193842-2017-00023
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    December 5, 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
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED TO CONFIRM IF THE REPORTED PATIENT INJURY 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. THIS MDR IS IN RELATION TO THE FIRST LOTUS INTRODUCER DEVICE (PLACED ON THE LEFT FEMORAL ACCESS). A SECOND MDR IN RELATION TO THE DEVICE PLACED ON THE RIGHT FEMORAL ACCESS HAS ALSO BEEN SUBMITTED AS PER MDR MFR REPORT NUMBER 3004193842-2017-00024. 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 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MDR IS DUE TO THE FOLLOWING ADDITIONAL INFORMATION RECEIVED ON 11-JAN-2018; WHAT WAS THE INJURY ON THE LEFT SIDE (I.E. DISSECTION, PERFORATION) AND WHERE WAS IT LOCATED (FEMORAL, ETC)? LOCATED AT THE FEMORAL AREA.. LOOKED TO BE A DISSECTION. -WHAT WAS THE INJURY ON THE RIGHT SIDE (I.E. DISSECTION, PERFORATION) AND WHERE WAS IT LOCATED (FEMORAL, ETC)? LOCATED AT THE FEMORAL AREA AND LOOKED TO BE A DISSECTION WAS EITHER PATIENT INJURY DIRECTLY CAUSED BY OUR LOTUS INTRODUCER SHEATH? PLEASE SPECIFY WHICH SIDE(S). NOT AVAILABLE, NOR MENTIONED BY PHYSICIANS. IF SO, WAS THE STENT PLACEMENT SPECIFICALLY TO RESOLVE OR RELATED TO THE INJURY CAUSED BY THE LOTUS INTRODUCER SHEATH? DID THE PATIENT FULLY RECOVER? YES. WHAT ARE THE BATCH NUMBERS FOR THE LOTUS INTRODUCERS? PLEASE INDICATE THE LOCATION WHERE EACH WAS USED (LEFT OR RIGHT)? LIS-S: 416152 (LEFT FEMORAL) ; LIS-S 423684 (RIGHT FEMORAL). THIS MDR IS IN RELATION TO THE FIRST LOTUS INTRODUCER DEVICE (PLACED ON THE LEFT FEMORAL ACCESS). A SECOND MDR IN RELATION TO THE DEVICE PLACED ON THE RIGHT FEMORAL ACCESS HAS ALSO BEEN SUBMITTED AS PER MDR MFR REPORT NUMBER 3004193842-2017-00024. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 416152 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. AS OF 02-FEB-2018, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH LOT NUMBER 416152, FOR THE AS REPORTED FAILURES INTRODUCER SHEATH - DIFFICULTY ADVANCING A SHIP HISTORY REVIEW WAS COMPLETED AND FOUND THAT 191 UNITS FROM THE LOT# 416152 WERE SHIPPED TO (B)(4) DISTRIBUTION CENTRE, (B)(4) ON 15-SEP-2017. 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 (B)(6) 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 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; "LEFT FEMORAL ACCESS WAS CHOSEN BY PHYSICIANS, HOWEVER WHILE TRYING TO ADVANCE THE LOTUS-S INTRODUCER PHYSICIANS WERE UNABLE TO SUCCESSFULLY ADVANCE THE INTRODUCER INTO THE PROPER POSITION. ONCE THE SYSTEM WAS TAKEN OUT IT WAS NOTED THAT THE PATIENT WOULD REQUIRE A STENT. A STENT WAS PUT IN AND THE ISSUE WAS RESOLVED. IT WAS THEN DECIDED TO TRY THE RIGHT FEMORAL ACCESS WITH A DIFFERENT LOTUS-S INTRODUCER. WHILE TRYING TO ADVANCE THE LOTUS-S PHYSICIANS WERE UNABLE TO SUCCESSFULLY ADVANCE THE INTRODUCER. PATIENT ALSO REQUIRED STENTS IN THE RIGHT FEMORAL SIDE. 2 DAYS AFTER THE PROCEDURE WE WERE TOLD THE PATIENT IS STABLE AND RECOVERING JUST FINE." THIS MDR IS IN RELATION TO THE FIRST LOTUS INTRODUCER DEVICE (PLACED ON THE LEFT FEMORAL ACCESS). A SECOND MDR REPORT IN RELATION TO THE DEVICE PLACED ON THE RIGHT FEMORAL ACCESS HAS ALSO BEEN SUBMITTED AS PER MDR REPORT MFR REPORT NUMBER 3004193842-2017-00024.

    Description of Event or Problem · 1

    INITIAL COMPLAINT DESCRIPTION RECEIVED IS AS FOLLOWS;"LEFT FEMORAL ACCESS WAS CHOSEN BY PHYSICIANS, HOWEVER WHILE TRYING TO ADVANCE THE LOTUS-S INTRODUCER PHYSICIANS WERE UNABLE TO SUCCESSFULLY ADVANCE THE INTRODUCER INTO THE PROPER POSITION. ONCE THE SYSTEM WAS TAKEN OUT IT WAS NOTED THAT THE PATIENT WOULD REQUIRE A STENT. A STENT WAS PUT IN AND THE ISSUE WAS RESOLVED. IT WAS THEN DECIDED TO TRY THE RIGHT FEMORAL ACCESS WITH A DIFFERENT LOTUS-S INTRODUCER. WHILE TRYING TO ADVANCE THE LOTUS-S PHYSICIANS WERE UNABLE TO SUCCESSFULLY ADVANCE THE INTRODUCER. PATIENT ALSO REQUIRED STENTS IN THE RIGHT FEMORAL SIDE. 2 DAYS AFTER THE PROCEDURE WE WERE TOLD THE PATIENT IS STABLE AND RECOVERING JUST FINE."THIS MDR IS IN RELATION TO THE FIRST LOTUS INTRODUCER DEVICE (PLACED ON THE LEFT FEMORAL ACCESS). A SECOND MDR REPORT IN RELATION TO THE DEVICE PLACED ON THE RIGHT FEMORAL ACCESS HAS ALSO BEEN SUBMITTED AS PER MDR REPORT MFR REPORT NUMBER 3004193842-2017-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21740 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR180 416152

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R