UNKNOWN EMPRINT GENERATOR
Report
- Report Number
- 1717344-2025-00052
- Event Type
- Injury
- Date Received
- January 9, 2025
- Date of Event
- February 12, 2024
- Report Date
- March 3, 2025
- Manufacturer
- COVIDIEN MFG DC BOULDER
- Product Code
- NEY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
D10 CONCOMITANT PRODUCTS: UNK EMPRINT ANT - UNKNOWN EMPRINT ANTENNA, LOT# UNKNOWN UNK - EMPRINT GEN -UNKNOWN EMPRINT GENERATOR UNK EMPRINT ANT - UNKNOWN EMPRINT ANTENNA, LOT# UNKNOWN LITERATURE EVENTS: AUTHOR: CALVIN SZE HANG NG TITLE: SAFETY AND FEASIBILITY OF TRANSBRONCHIAL MICROWAVE ABLATION FOR SUBPLEURAL LUNG NODULES SOURCE: DOI: 10.1177/02184923241228323. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CORRECTION: B5 ADDITIONAL INFORMATION: G3. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE LITERATURE, FROM MARCH 2019 TO NOVEMBER 2022, 77 PATIENTS WITH 82 LUNG NODULES WERE TREATED WITH TRANSBRONCHIAL MWA IN THE HYBRID OPERATING THEATER AND ULTIMATELY INCLUDED IN THIS ANALYSIS; INCLUDING FIVE PATIENTS WITH TWO LUNG NODULES ABLATED IN TWO SEPARATE OPERATIVE SESSION. IN TOTAL, 21 CASES (25.6%) OF POSTOPERATIVE COMPLICATIONS WERE REPORTED. PNEUMOTHORAX REQUIRING DRAINAGE (5/82). OF THESE, 5 CASES WERE LIKELY DUE TO THE INADVERTENT PUNCTURE OF PLEURA DURING INSTRUMENT EXCHANGE (SUCH AS TRANSBRONCHIAL TOOLS). ONE CASE OF PNEUMOTHORAX WAS DUE TO A SIGNIFICANT TISSUE CONTRACTION DURING THE ABLATION PROCESS, LEADING TO SHIFTING OF THE CATHETER. BRONCHOPLEURAL FISTULA (1/82) REQUIRING READMISSION FOR PLEURAL DRAINAGE AND ENDOBRONCHIAL VALVE REPLACEMENT, PNEUMONIA/INFECTION (2/82) ONE WAS TREATED WITH A ROUTINE COURSE OF ORAL ANTIBIOTICS AND THE OTHER WAS TREATED WITH A PROLONGED COURSE OF ANTIBIOTICS. NONE OF THE COMPLICATIONS MENTIONED IN THIS COHORT WERE DIRECTLY RELATED TO THE DEVICE.
ACCORDING TO THE REPORTER, FROM MARCH 2019 TO NOVEMBER 2022, 77 PATIENTS WITH 82 LUNG NODULES WERE TREATED WITH TRANSBRONCHIAL MWA IN THE HYBRID OPERATING THEATER AND ULTIMATELY INCLUDED IN THIS ANALYSIS; INCLUDING FIVE PATIENTS WITH TWO LUNG NODULES ABLATED IN TWO SEPARATE OPERATIVE SESSION. IN TOTAL, 21 CASES (25.6%) OF POSTOPERATIVE COMPLICATIONS WERE REPORTED. PNEUMOTHORAX REQUIRING DRAINAGE (5/82), BRONCHOPLEURAL FISTULA (1/82) REQUIRING READMISSION FOR PLEURAL DRAINAGE AND ENDOBRONCHIAL VALVE REPLACEMENT, PNEUMONIA/INFECTION (2/82) ONE WAS TREATED WITH A ROUTINE COURSE OF ORAL ANTIBIOTICS AND THE OTHER WAS TREATED WITH A PROLONGED COURSE OF ANTIBIOTICS.
ACCORDING TO THE LITERATURE, FROM MARCH 2019 TO NOVEMBER 2022, 77 PATIENTS WITH 82 LUNG NODULES WERE TREATED WITH TRANSBRONCHIAL MWA IN THE HYBRID OPERATING THEATER AND ULTIMATELY INCLUDED IN THIS ANALYSIS; INCLUDING FIVE PATIENTS WITH TWO LUNG NODULES ABLATED IN TWO SEPARATE OPERATIVE SESSION. IN TOTAL, 21 CASES (25.6%) OF POSTOPERATIVE COMPLICATIONS WERE REPORTED. PNEUMOTHORAX REQUIRING DRAINAGE (5/82), BRONCHOPLEURAL FISTULA (1/82) REQUIRING READMISSION FOR PLEURAL DRAINAGE AND ENDOBRONCHIAL VALVE REPLACEMENT, PNEUMONIA/INFECTION (2/82) ONE WAS TREATED WITH A ROUTINE COURSE OF ORAL ANTIBIOTICS AND THE OTHER WAS TREATED WITH A PROLONGED COURSE OF ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1169663 | UNKNOWN EMPRINT GENERATOR | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | NEY | COVIDIEN MFG DC BOULDER | UNKNOWN EMPRINT GENERATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Required Intervention| H| O | SEE H11 |