MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-10 for EMPRINT CA20L2 manufactured by Covidien Medical Products.
[174652310]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[174652311]
After microwave ablation therapy was performed, it resulted in intraperitoneal bleeding and the patient died. According to computerized tomography (ct) examination, it was considered that the bleeding was from the route of puncture. It was also noted by the doctor that the bleeding occurred from the antenna puncture route due to hepatic artery damage at treated site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006451981-2020-00008 |
| MDR Report Key | 9578608 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-09-04 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN MEDICAL PRODUCTS |
| Manufacturer Street | BUILDING 10- NO 789 PUXING ROA |
| Manufacturer City | SHANGHAI 201114 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 201114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMPRINT |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-01-10 |
| Model Number | CA20L2 |
| Catalog Number | CA20L2 |
| Lot Number | S9JG008X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MEDICAL PRODUCTS |
| Manufacturer Address | BUILDING 10- NO 789 PUXING ROA SHANGHAI 201114 CN 201114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-10 |