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

Model Number 64082-01

Device Problems Inflation Problem (1310); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2021

Event Type  malfunction  

Event Description

Covidien barrx 360 express rfa balloon catheter would not inflate and reading faulty catheter, opened another catheter and it did the same.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11692638
• MDR Text Key: 246264126
• Report Number: 11692638
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: (01)10884521211599(17)230706(10)F2514912X
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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: F2514912X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 58