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

Model Number 64082-01

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Event Description

Patient undergoing esophagogastroduodenoscopy (egd) with ablation.Medtronic vendor rep present for case support.The barrx radiofrequency ablation (rfa) self-sizing balloon catheter would not inflate on the second pass.The medtronic rep instructed the physician and/or staff to disconnect and reconnect all cables, restart equipment and ensure tight seal but all efforts were unsuccessful.A second rfa balloon was opened, used and procedure was completed without further incident.No patient harm.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12518695
• MDR Text Key: 272891142
• Report Number: 12518695
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 64082-01
• Device Catalogue Number: 64082-01
• Device Lot Number: F2512338X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 92