MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number 64082

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

Patient Problems Airway Obstruction (1699); Fever (1858); Swelling/ Edema (4577)

Event Date 12/13/2023

Event Type  Injury  

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

According to the reporter, the patient was experiencing laryngospasm post rfa (radiofrequency ablation).Ent suspected nerve damage.After interventions, anesthesia could not control the spasms medically or manually.Patient had to be intubated again and has since been in the icu.Patient developed stridor, was given steroid, and wound up being re-intubated.Patient was also given epinephrine at some point.Ent had performed laryngoscopy while the patient was intubated.The area appeared edematous, with no focal laceration identified.Eventually, an attempt to extubate was unsuccessful.Another endoscopy was performed around this time and visually evaluated area of prior ablation.There was no focal laceration identified in the area of treatment.There had been a plan to extubate but the patient wound up developing a fever, and decision was made to hold off.The patient was not tolerating being extubated particularly well and wound up being trached.Had another laryngoscopy, and the ent physician did not seem to feel like this was traumatic.Ent seemed to think it was plausible that it was rfa related.Patient trached and fenestrated.Speech therapy has been involved.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18485218
• MDR Text Key: 332565222
• Report Number: 3004904811-2024-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: 10884521211599
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 64082
• Device Catalogue Number: 64082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White