MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN GENERATOR; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number UNKNOWN GENERATOR

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

Patient Problems Burn(s) (1757); Unspecified Infection (1930); Pneumothorax (2012); No Code Available (3191)

Event Date 06/06/2015

Event Type  Injury  

Manufacturer Narrative

Title: major complications of high-energy microwave ablation for percutaneous ct-guided treatment of lung malignancies: single-centre experience after 4 years.Source: journal of medical imaging and radiation oncology.59 (10), (609-616), 2015.Date of publication: 06 jun 2015.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Pli-10: according to the literature source performed from may 2010 to september 2014 , after being treated with percutaneous computed tomography (ct)-guided microwave ablation (mwa) of primary and secondary lung malignancies.The patient suffered from pneumothorax, large effusion, pulmonary hemorrhage, infection, chest wall burn and pleural seeding.They used the evident¿ system operating at 915 mhz with maximum power output of 45 w, and 13g antennae with a 2 cm or a 3.7 cm active tip.For the remaining 62 cases (88.6% of patients) they used a higher powered acculis microwave tissue ablation system (angiodynamics), operating at 2.45 ghz with a maximum power output of 140 w (power applied was 80 w to 120 w).Pli-20: after being treated with microwave ablation for single, focal hepatic malignancies, patient suffered death.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN GENERATOR
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8245778
• MDR Text Key: 132991994
• Report Number: 1717344-2019-00086
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN GENERATOR
• Device Catalogue Number: UNKNOWN GENERATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR