MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) RF FOOTSWITCH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 34-109-1

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

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 02/10/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator, footswitch, and corecath.It was reported that during the case the patient had bleeding the endotracheal tube and there was medical intervention needed.The physician reported the patient had passed away.The physician¿s stated that a normal patient could have bounced back from blood pressure and cardiac arrest but due to the patient being terminally ill he just could not recover.Additional information was received from a rep.It was reported that cause of the bleeding was hemorrhagic tumor.Physician stated this was not the cause of death.It was noted that the bleeding was related to the treatment of the tumor.There were no product deficiencies with the corecath, footswitch, or generator.It was unknown if the device contributed to the death or was the bleeding related to the patients underlying diagnosis.Intervention tried was cold saline and topical epinephrine were used successfully to contain and stop the bleeding.Additionally, it was reported that the corecath was discarded and the generator and the footswitch was still in use and will not be return.Lot number were provided.

Manufacturer Narrative

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.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacture representative (rep).It was reported that the hcp stated the patient developed cardiac arrest and loss of blood pressure due to the procedure which he could not recover from.The hcp did note that a normal, healthy patient could have bounced back from the blood pressure and cardiac arrest that happened during the procedure, but due to the patient being terminally ill he could not recover.The hcp also stated that the patient lost 70 pounds recently and was about to be put on hospice and was very sick.The hcp noted he controlled the bleeding quickly and the patient¿s heart and blood pressure never recovered.The physician also stated the patient had a computed tomography angiography (cta) of the chest done before the procedure that showed a very large airway obstruction the size of a hotdog.The hcp stated that he was in the airway the whole time and that the bleeding was contained.The hcp also stated the patient had pulseless electrical activity (pea).

• Brand Name: RF FOOTSWITCH
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 9802599
• MDR Text Key: 182508174
• Report Number: 1226420-2020-00035
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K073057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 34-109-1
• Device Catalogue Number: 34-109-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82