BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 7240457 · Received February 5, 2018

    Report

    Report Number
    3004193842-2018-00002
    Event Type
    Death
    Date Received
    February 5, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 26, 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

    THIS FOLLOW-UP MDR IS TO GIVE AN UPDATE ON THE INVESTIGATION FINDINGS BY CREGANNA MEDICAL IN RELATION TO THIS EVENT AS FOLLOWS: AS OF 22-FEB-2018, WHEN THE REVIEW WAS COMPLETED, THE FOLLOWING INFORMATION WAS RECEIVED. THE OFFICIAL CAUSE OF DEATH WAS HEART FAILURE AFTER VALVULOPLASTY. THERE WAS NO AUTOPSY PERFORMED. ONLY THE LOTUS INTRODUCER, IT WAS USED TO INTRODUCE THE BALLOON FOR THE VALVULOPLASTY. IN THE PHYSICIAN'S OPINION, THE DEVICE(S) WERE NOT RELATED TO THE PATIENT'S DEATH. THE PATIENT'S LOSS OF "NORMAL PRESSURE" DURING VALVULOPLASTY WAS THE RAPID PACING NECESSARY TO DROP THE PATIENT PRESSURE AND DO THE VALVULOPLASTY, USUALLY PATIENT RECOVERS NORMAL PRESSURE AFTER THIS BUT NOT IN THIS CASE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 423684 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 423684, FOR THE AS REPORTED FAILURES INTRODUCER SHEATH - DIFFICULTY ADVANCING A SHIP HISTORY REVIEW WAS COMPLETED AND FOUND THAT (B)(4) UNITS FROM THE LOT# 423684 WERE SHIPPED TO (B)(4) ON 20-OCT-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 THE MANUFACTURING SITE 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 OF A POTENTIAL PROCESSING OR DESIGN FAILURE ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING SITE THEREFORE A TECHNICAL ANALYSIS COULD NOT BE COMPLETED. THEREFORE THE ROOTCAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'CAUSED BY OTHER'. CAUSED BY OTHER IS DEFINED AS WHERE 'THE COMPLAINT INVESTIGATION INDICATES ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT EVENT' THERE IS NO EVIDENCE OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. BASED ON THE ABOVE A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS NOT REQUIRED FOR THIS COMPLAINT. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS. OR THIS INITIAL...

    Description of Event or Problem · 1

    INITIAL COMPLAINT DESCRIPTION RECEIVED IS AS FOLLOWS: BEFORE IMPLANTING THE VALVE, A VALVULOPLASTY WAS NECESSARY TO DO THIS PROCEDURE. THEY DID IT WITH RAPID PACING OF THE PATIENT. AFTER THE VALVULOPLASTY THE PATIENT NEVER RECOVERED THE NORMAL PRESSURE. RESUSCITATION MANOUVERS WERE DONE FOR ABOUT 40 MINS BUT THE PATIENT NEVER RECOVERED THE PRESSURE AND DIED. SO THE VALVE COULDN'T BE IMPLANTED LATER. WHAT WAS THE OFFICIAL CAUSE OF DEATH? HEART FAILURE AFTER VALVULOPLASTY. WAS AN AUTOPSY PERFORMED? NO. IN THE PHYSICIAN'S OPINION, WHICH DEVICE(S) WERE RELATED TO THE PATIENT'S DEATH? NO DEVICE RELATED. HAD ANY OF THE BSC DEVICES (INTRODUCER, DELIVERY SYSTEM, VALVE) BEEN INTRODUCED INTO THE PATIENT PRIOR TO THE PATIENT'S DEATH? IF YES, PLEASE DESCRIBE IN DETAIL. ONLY THE LOTUS INTRODUCER, IT WAS USED TO INTRODUCE THE BALLOON FOR THE VALVULOPLASTY. WHAT CAUSED THE PATIENT TO LOSE "NORMAL PRESSURE" DURING VALVULOPLASTY? THE RAPID PACING IS NECESSARY TO DROP THE PATIENT PRESSURE AND DO THE VALVULOPLASTY , USUALLY PATIENT RECOVERS NORMAL PRESSURE AFTER THIS.'

    Description of Event or Problem · 1

    INITIAL COMPLAINT DESCRIPTION RECEIVED IS AS FOLLOWS: 'PER TELEPHONE: BEFORE IMPLANTING THE VALVE, A VALVULOPLASTY WAS NECESSARY TO DO THIS PROCEDURE. THEY DID IT WITH RAPID PACING OF THE PATIENT. AFTER THE VALVULOPLASTY THE PATIENT NEVER RECOVERED THE NORMAL PRESSURE. RESUSCITATION MANOEUVERS WERE DONE FOR ABOUT 40 MINS BUT THE PATIENT NEVER RECOVERED THE PRESSURE AND DIED. SO THE VALVE COULDN'T BE IMPLANTED LATER. WHAT WAS THE OFFICIAL CAUSE OF DEATH? HEART FAILURE AFTER VALVULOPLASTY WAS AN AUTOPSY PERFORMED? NO IN THE PHYSICIAN'S OPINION, WHICH DEVICE(S) WERE RELATED TO THE PATIENT'S DEATH? NO DEVICE RELATED HAD ANY OF THE BSC DEVICES (INTRODUCER, DELIVERY SYSTEM, VALVE) BEEN INTRODUCED INTO THE PATIENT PRIOR TO THE PATIENT'S DEATH? IF YES, PLEASE DESCRIBE IN DETAIL. ONLY THE LOTUS INTRODUCER, IT WAS USED TO INTRODUCE THE BALLOON FOR THE VALVULOPLASTY. WHAT CAUSED THE PATIENT TO LOSE "NORMAL PRESSURE" DURING VALVULOPLASTY? THE RAPID PACING IS NECESSARY TO DROP THE PATIENT PRESSURE AND DO THE VALVULOPLASTY , USUALLY PATIENT RECOVERS NORMAL PRESSURE AFTER THIS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85269 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL H749NTR180 423684

    Patients

    Seq Age Sex Outcome Treatment
    1 Death