BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE PR XT PROBE 20CM 15GA

    MDR report key: 13042452 · Received December 20, 2021

    Report

    Report Number
    3008769756-2021-00100
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 26, 2021
    Report Date
    December 20, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006425
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/21/2021 UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH #: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS PATIENT RE-ADMITTED AFTER BEING DISCHARGED, WITHOUT ANY COMPLAINTS, ON NOVEMBER 26TH? CORRECT, PATIENT WAS DISCHARGED IN THE MORNING ON 26-NOV AND LATER THAT DAY, IN THE EVENING RE-ADMITTED BECAUSE OF PAIN COMPLAINTS. THEN THE NEXT DAY DISCHARGED AGAIN AFTER PAIN WAS UNDER CONTROL WITH PAIN MEDICATION. TO KNOW WHAT THE REASONS ARE THAT THIS EVENT COULD POSSIBLY BE RELATED TO THE STUDY DEVICE AND IS THIS FURTHER INVESTIGATED? HAS THERE BEEN A DEVICE ISSUE? NO, BUT THE DEFINITION OF THIS IS NOT ENTIRELY CLEAR TO ME (I CAN'T SEE IT IN ECRF EITHER). THERE WAS NO FAILURE OF THE DEVICE, BUT COMPLICATION IS OF COURSE VERY POSSIBLE RELATED TO THE APPLICATION OF THE ABLATION (IN ACCORDANCE WITH ALL REGULATIONS AND NORMAL PROCEDURES). NOT WITH THE DEVICE ITSELF. CAN YOU PROVIDE A SUMMARY OF THIS EVENT FOR THE MEDICAL TEAM FOR REVIEW? NOV 25 PERCUTANEOUS MWA AT 2X HCC SEGMENT 8 AND SEGMENT 2. FIRST LESION (SEG.8) TWO ABLATIONS 10 MIN 65W AND ADDITIONAL 5 MIN 65W WITH 2X PR20XT. SECOND LESION (SEG. 2) IN CLOSE RELATION TO THE STOMACH FOR WHICH CO2 WAS INTRODUCED PRIOR TO INITIATION OF ABLATION TO DEVIATE THE STOMACH. WITH GOOD RESULT, ABLATION STARTS, 2 NEEDLES 10 MIN 65W AND ADDITIONAL 1 NEEDLE 10 MIN 65W. NO COMPLICATIONS ON POST-ABLATION CT. PT. RECOVERS WELL IN THE WARD AND CAN GO HOME THE NEXT DAY IN THE MORNING. IN THE COURSE OF THAT EVENING SHE HAS PAIN IN THE UPPER ABDOMEN AND RETURNS TO THE EMERGENCY ROOM. AFTER ANALYSIS, A CT ABDOMEN IS MADE WHICH SHOWS NO INDICATIONS OF BLEEDING OR PERFORATION (AFTER THE PROCEDURE SOME AIR IS STILL PRESENT IN THE ABDOMINAL CAVITY DUE TO CO2 DISSECTION). THE PAIN MAY BE RELATED TO ABLATION CLOSE TO DIAPHRAGM (LESION SEG. 8) OR RELATED TO CO2 IN THE ABDOMINAL CAVITY. MRS. IS ADMITTED FOR OBSERVATION. AFTER STARTING OXYCODONE, PAIN IS ACCEPTABLE AND MRS. BACK HOME THE NEXT MORNING. NOT ENOUGH DATA PROVIDED TO PERFORM A CALL HOME INVESTIGATION. NO DEVICE WILL BE RETURNED TO NEUWAVE FOR FURTHER INVESTIGATION. THE ROOT CAUSE IS UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE DURING A CLINICAL TRIAL THE PATIENT EXPERIENCED ABDOMINAL PAIN. IT REQUIRED ADDITIONAL HOSPITALIZATION, DRUG THERAPY, DIAGNOSTIC IMAGING, AND OBSERVATION. THERE IS A POSSIBLE RELATIONSHIP TO THE STUDY DEVICE. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941610 NEUWAVE PR XT PROBE 20CM 15GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. PR20XT 00853719006425

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention