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 Problem Death (1802)

Event Date 06/06/2015

Event Type  Death  

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.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: according to the literature source performed from may 2010 to september 2014, 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.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
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8245775
• MDR Text Key: 132994625
• Report Number: 1717344-2019-00085
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 66 YR