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

Model Number	64082-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Covidien barrx 360 rfa (radiofrequency ablation) balloon catheter malfunction.During the procedure, the catheter stopped working while it was being used.Able to do 3 treatments and then it stopped during the fourth inflation and ablation.Tried troubleshooting the device, but was unable to get it working again.Opened another rfa balloon catheter from the same lot and that one worked with no faults.No harm to pt, procedure completed.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13577098
• Report Number: 13577098
• Device Sequence Number: 4410312
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: (01)10884521211599(17)240719(10)F2518933X
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/15/2022
• Report Date (Section F): 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 64082-01
• Device Lot Number: F2518933X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 84 KG
• Patient Race: White
• Date Report Sent to FDA: 02/15/2022