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

Model Number 90-9010

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Chest Pain (1776)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the output cable was not working properly so the balloon did not deflate after the first round of ablation that lasted longer.They did not find the pneumatic searches for the diameter.The physician attempted to ablate and double burned the patient.The patient received circumferential ablation as first step.After the unusual deflation of the catheter caused by the output cable, the catheter was removed and checked, and it worked with a new output cable.However, because their first doubt was related to the efficiency of the 360-express catheter, they completed the procedure with a 90-focal catheter.They stated that the procedure was not smooth because of the defective output cable.The burn was not severe, but it caused some chest pain and the patient remained at the hospital with no further complications.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 10701933
• MDR Text Key: 212066180
• Report Number: 3004904811-2020-00033
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90-9010
• Device Catalogue Number: 90-9010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• 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): Hospitalization; Required Intervention