BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15 CM IRE SINGLE ELECTRODE

    MDR report key: 11900018 · Received May 28, 2021

    Report

    Report Number
    1317056-2021-00111
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    UDI-DI
    H787204001070
    PMA / PMN Number
    K080287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS BEING TRACKED AND REPORTED THROUGH THE DIRECT IDE TRIAL ASSOCIATED WITH PATIENT # (B)(4) OF THE DIRECT IDE TRIAL STUDY. THIS EVENT WILL BE ADJUDICATED BY THE CLINICAL ENDPOINTS COMMITTEE (CEC) AT A LATER DATE TO DETERMINE RELATIONSHIP WITH IDE. THIS REPORT IS BEING SUBMITTED TO CLOSE OUT THE COMPALINT FILE. REFERENCE (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT FILE IS BEING CANCELED AS IT IS BEING TRACKED AND REPORTED THROUGH THE DIRECT IDE TRIAL ASSOCIATED WITH PATIENT # (B)(6) OF THE DIRECT IDE TRIAL STUDY. THIS EVENT WILL BE ADJUDICATED BY THE CLINICAL ENDPOINTS COMMITTEE (CEC) AT A LATER DATE TO DETERMINE RELATIONSHIP WITH IDE.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT POST PROCEDURE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION OR PATIENT COMPLICATION DURING THE PROCEDURE. REFERENCE (B)(4).

    Description of Event or Problem · 1

    AN INTERVENTIONAL RADIOLOGIST REPORTED THE FOLLOWING INCIDENT, POST IRE/ NANOKNIFE PROCEDURE, TO AN ANGIODYNAMICS TERRITORY MANAGER: "I WAS CALLED ON 05/11/21 BY DR. (B)(6) REGARDING A PATIENT TREATED ON (B)(6) 2021 SURGICALLY IN THE OR AT UF SHANDS IN (B)(6). IT IS MY UNDERSTANDING THAT THE PATIENT RECEIVED A PANCREATIC RESECTION, WITH IRE/NANOKNIFE AND IS ENROLLED IN THE REGISTRY OF THE DIRECT TRIAL. ON THE EVENING OF (B)(6) 2021 DR. (B)(6) CALLED ME TO NOTIFY ME THAT THE PATIENT HAD EXPERIENCE COMPLICATIONS DUE TO THE SURGERY AND THE FAMILY HAD CHOSEN TO TRANSITION THE PATIENT TO COMFORT CARE OR HOSPICE RATHER THAN SEEK ADDITIONAL INTERVENTIONS. DR. (B)(6) LET ME KNOW THAT THE PATIENT WAS STILL ALIVE BUT WAS EXPECTED TO PASS AWAY IN THE COMING DAYS. DR. HEITHAUS ALSO STATED THAT THE CAUSE OF THE COMPLICATION WAS UNDETERMINED. IT IS NOT KNOWN IF IT WAS A COMPLICATION RELATED TO THE SURGICAL PROCEDURE, RESECTION, OR IRE PORTION OF THE SURGERY. I SPOKE WITH DR. (B)(6) ON THE MORNING OF (B)(6) 2021 TO CHECK ON THE PATIENT STATUS AND HE HAD NO UPDATE AT THE TIME." ADDITIONAL INFORMATION RECEIVED ON MAY 13, 2021, REPORTED THE PATIENT HAD NOT EXPIRED AS OF YET. IT WAS REPORTED BY THE PHYSICIAN, THAT THE PATIENT COMPLICATIONS WERE RELATED TO AN INFECTION THAT HAD DEVELOPED A WEEK OR MORE OUT FROM SURGERY, DURING WHICH TIME THE PATIENT IGNORED THEIR SYMPTOMS. THERE WAS NO SUSPICION OR ALLEGATION THAT THE NANOKNIFE SYSTEM CONTRIBUTED TO OR CAUSED THE PATIENT ISSUE. IT WAS INDICATED THAT THE ASSOCIATED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796615 15 CM IRE SINGLE ELECTRODE LOW ENERGY DIRECT CURRENT ABLATION SYSTEM OAB ANGIODYNAMICS 20400107 UNKNOWN H787204001070

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other