MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS UNKNOWN EMPRINT ANTENNA; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number UNKNOWN EMPRINT ANTENNA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pneumothorax (2012); Cancer (3262); Thrombosis/Thrombus (4440)

Event Date 03/28/2021

Event Type  malfunction  

Manufacturer Narrative

Title: computed tomography-guided microwave ablation of perivascular liver metastases from colorectal cancer: a study of the ablation zone, feasibility, and safety source: international journal of hyperthermia 2021, vol.38, no.1, 887¿899.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study compared the safety and efficacy of microwave ablation (mwa) in the treatment of perivascular versus non-perivascular liver metastases from colorectal cancer between june 2017 and june 2019.It is noted that mwa was performed using the imprint microwave ablation system.There were 84 patients included in the study and complications included: abscessed collection in the thermal ablation zone, complicated by a septic right supra hepatic venous thrombosis, treated with percutaneous drainage, perihepatic hemorrhage with active arterial bleeding treated with embolization, pneumothorax treated with drainage and biloma that required extended hospitalization.

• Brand Name: UNKNOWN EMPRINT ANTENNA
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13015587
• MDR Text Key: 282389073
• Report Number: 3006451981-2021-00174
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EMPRINT ANTENNA
• Device Catalogue Number: UNKNOWN EMPRINT ANTENNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1