BEUDAMED
    FDA Adverse Event Death Summary report: N

    20CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5019112 · Received August 20, 2015

    Report

    Report Number
    3006451981-2015-00184
    Event Type
    Death
    Date Received
    August 20, 2015
    Date of Event
    July 8, 2015
    Report Date
    August 7, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 08/202015. DATE OF FOLLOW-UP REPORT: 09/14/2015.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED BY THE DOCTOR: THE DOCTOR CONFIRMED THAT THE PATIENT HAD SEVERE EMPHYSEMA, AND A 1.5-2 CM LESION IN THE LUL. HE HAD TO ATTEMPT TO PUNCTURE THE LESION SEVERAL TIMES BUT STATES THAT HE DID NOT CROSS A FISSURE. THE PNEUMO WAS IDENTIFIED PRIOR TO THE ABLATION AND A PIGTAIL WAS PLACED. THE PROCEDURE WAS UNCOMPLICATED OTHERWISE. THE PATIENT WAS STABLE POST PROCEDURE BUT IT WAS LATE IN THE DAY SO THE PATIENT STAYED THE NIGHT AND WAS DISCHARGED THE NEXT DAY WITHOUT THE PIGTAIL. HE RETURNED APPROXIMATELY ONE WEEK LATER AND WAS DIAGNOSED BY CHEST X-RAY WITH PNEUMONIA. THE DOCTOR DID NOT FOLLOW THE CASE CLOSELY AFTER THAT BUT WAS TOLD THAT THE PATIENT DEVELOPED ARDS AND EVENTUAL RESPIRATORY ARREST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS OLDER WITH BAD EMPHYSEMA. HE WAS DEEMED MEDICALLY INOPERABLE SO ABLATION WAS CHOSEN AS TREATMENT (LUNG ABLATION, UPPER LEFT LOBE). THE ANTENNA WAS PLACED VIA CT GUIDANCE. AN OPERATING SET UP WAS CREATED IN IR SUITE IN THE EVENT THEY NEEDED TO CONVERT TO SURGERY DURING THE CASE. THE PROCEDURE WAS REPORTED TO HAVE GONE WELL. THE PATIENT HAD A MILD PNEUMOTHORAX POST PROCEDURE, DETECTED 6-7 MIN INTO THE CASE, AND THE DOCTOR PLACED A PIGTAIL DRAIN. WITHIN A WEEK, AN IMAGE WAS TAKEN TO DETERMINE IF THE DRAIN COULD BE DISCONTINUED AND THEY SAW PNEUMONITIS/INFILTRATES. ON IMAGING IT WAS NOTED THERE WERE BLACK AIR SPACES. PNEUMONIA WAS SUSPECTED AND PATIENT WAS TREATED FOR PNEUMONIA, BUT FOUND LATER THERE WAS NO INFECTIOUS COMPONENT. THE PATIENT WAS REPORTED TO HAVE LEFT THE HOSPITAL BUT RETURNED SEVERAL DAYS LATER. THE PATIENT DEVELOPED RESPIRATORY DISTRESS AND WAS INTUBATED. THE PATIENT THEN EXPIRED (DATE NOT REPORTED). HAS TREATED OTHER EMPHYSEMA PATIENTS WITHOUT DIFFICULTY BUT DOES BELIEVE THAT EMPHYSEMA MAY HAVE CONTRIBUTED TO THE OUTCOME. HE HAD DIFFICULTY PENETRATING THE LESION WITH THE ANTENNAE TIP. HE MADE MULTIPLE PASSES. (B)(6) REPORTS THE PATIENT MAY HAVE BLED, AND IF SO IT IS POSSIBLE THAT THE "PNEUMONITIS" IDENTIFIED RADIOLOGICALLY WAS SECONDARY TO ASPIRATION. THE ONLY ACUTE ISSUE DURING THE PROCEDURE WAS A PNEUMO THAT WAS NOTED AND A PIGTAIL WAS PLACED. THE PATIENT LEFT THE HOSPITAL AND RETURNED SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553007 20CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) CA20L1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death