MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN RF ELECTRODE

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

Patient Problems Abscess (1690); Burn(s) (1757); Fistula (1862); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Pneumothorax (2012)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

Title: frequency and risk factors for major complications after stereotactic radiofrequency ablation of liver tumors in 1235 ablation sessions: a 15-year experience source: european radiology (2021) 31:3042¿3052 https://doi.Org/10.1007/s00330-020-07409-0.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study assessed the frequency of major complications following the treatment of liver tumors with multiprobe stereotactic radiofrequency ablation (srfa) between july 2003 and december 2018.It is noted that a maximum of three 17g cool-tip radiofrequency (rf) electrodes were introduced through coaxial needles for serial tumor ablation, which was further carried out using the unipolar cool-tip rf generator and cool-tip rf switching controller.There were 793 patients treated in 1235 srfa sessions and complications included: thermal damage to hollow viscera, skin, and central bile ducts, which required additional surgery and/or endoscopic retrograde cholangiopancreatography (ercp ) with ultrasound (us)-guided drainage, pleuro-cutaneous fistula secondary to thermal injury, treated with a series of us-guided drainages, liver abscesses treated with surgical intervention or us-guided drainage,<(>,<)> arterio-portal fistula treated with angiographic coiling, peri-intrahepatic hemorrhage treated with angiographic coiling, major pleural effusion treated with thoracocentesis, and pneumothorax treated with chest tube insertion.

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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided 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.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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN RF ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12448107
• MDR Text Key: 270597347
• Report Number: 1717344-2021-01246
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN RF ELECTRODE
• Device Catalogue Number: UNKNOWN RF ELECTRODE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR