BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 6391178 · Received March 9, 2017

    Report

    Report Number
    3004193842-2017-00012
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    September 23, 2014
    Report Date
    May 8, 2017
    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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS TO GIVE AN UPDATE ON THE INVESTIGATION FINDINGS BY CREGANNA MEDICAL IN RELATION TO THIS EVENT AS FOLLOWS: LOT NUMBER WAS NOT PROVIDED THEREFORE IT IS NOT POSSIBLE TO COMPLETE A DHR/LHR REVIEW. LOT NUMBER WAS NOT PROVIDED THEREFORE IT IS NOT POSSIBLE TO COMPLETE A SIMILAR COMPLAINT TREND REVIEW. LOT NUMBER WAS NOT PROVIDED THEREFORE A SHIP HISTORY REVIEW COULD NOT BE COMPLETED. 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 THE MANUFACTURING SITE THEREFORE A TECHNICAL ANALYSIS COULD NOT BE COMPLETED. BASED ON A REVIEW OF THE FMEAS AND BASED ON THIS COMPLAINT INVESTIGATION NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH AT THIS TIME. THERE IS NO INDICATION OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. THE DEVICE WAS NOT RETURNED FOR REVIEW. DAMAGE TO THE VESSEL IS CONSIDERED IN MULTIPLE PLACES WITHIN THE RISK DOCUMENTATION AND IS NOT A NEW OR UNANTICIPATED FAILURE MODE. CREGANNA MEDICAL WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. BASED ON THE DEVICE REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'ANTICIPATED PROCEDURAL COMPLICATION'. 'ANTICIPATED PROCEDURAL COMPLICATION' IS DEFINED AS WHERE 'THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE INSTRUCTIONS FOR USE, AND OR DEVICE LABELING'. BASED ON THE ABOVE CONCLUSION THERE IS NO NEED TO ESCALATE THIS COMPLAINT ANY FURTHER. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS TO UPDATE THE INVESTIGATION SUMMARY WITH LOT INFORMATION (INCLUDING MANUFACTURE AND EXPIRY DATES OF DEVICE) WHICH WAS PROVIDED TO CREGANNA MEDICAL ON 11-APR-2017 AS FOLLOWS: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 240090 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 27 APRIL 2017, WHEN THE REVIEW WAS COMPLETED, THERE WAS ONE OTHER COMPLAINT (LOT-PC15-008) ASSOCIATED WITH LOT NUMBER 240090, FOR THE AS REPORTED FAILURE PATIENT - VESSEL DISSECTION. A SHIP HISTORY REVIEW WAS COMPLETED AND FOUND THAT (B)(4) UNITS FROM THE LOT# 240090 WERE SHIPPED TO (B)(4) ON 13-OCT-2014. 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 FMEAS AND BASED ON THIS COMPLAINT INVESTIGATION NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH AT THIS TIME. THERE IS NO INDICATION OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. THE DEVICE WAS NOT RETURNED FOR REVIEW. DAMAGE TO THE VESSEL IS CONSIDERED IN MULTIPLE PLACES WITHIN THE RISK DOCUMENTATION AND IS NOT A NEW OR UNANTICIPATED FAILURE MODE. WE WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. BASED ON THE DEVICE REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'ANTICIPATED PROCEDURAL COMPLICATION' WHICH IS DEFINED AS WHERE 'THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE INSTRUCTIONS FOR USE, AND OR DEVICE LABELLING'. BASED ON THE ABOVE CONCLUSION THERE IS NO NEED TO ESCALATE THIS COMPLAINT ANY FURTHER. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPRISE III 0304R3003 (RFA DISSECTION). SLIGHT DISSECTION IN FEMORAL. OPTIPRO BALLOON USED TO RESOLVE WITHOUT ISSUE. SECOND GUIDE WIRE USED AFTER FIRST KINKED UPON INSERTION OF BAV.

    Description of Event or Problem · 1

    INITIAL COMPLAINT DESCRIPTION RECEIVED: "REPRISE III 0304R3003 (RFA DISSECTION) SLIGHT DISSECTION IN FEMORAL. OPTIPRO BALLOON USED TO RESOLVE WITHOUT ISSUE. SECOND GUIDE WIRE USED AFTER FIRST KINKED UPON INSERTION OF BAV."

    Description of Event or Problem · 1

    INITIAL COMPLAINT DESCRIPTION RECEIVED: "REPRISE III 0304R3003 (RFA DISSECTION) SLIGHT DISSECTION IN FEMORAL. OPTIPRO BALLOON USED TO RESOLVE WITHOUT ISSUE. SECOND GUIDE WIRE USED AFTER FIRST KINKED UPON INSERTION OF BAV." ON 11-APR-2017, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: 'WE HAVE A BATCH NUMBER FOR THIS DEVICE; 240090'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173361 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR200 240090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention