MAUDE Adverse Event Report: COVIDIEN LP BARRX 360 CLASSIC SIZING BALLOON; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 64082

Device Problems Inflation Problem (1310); Gas/Air Leak (2946); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

Barrx 360 express balloon catheter malfunctioned.Balloon would not inflate.Stated, "air leak".Unplugged equipment and reconnected, reset halo device as stated on machine with no luck.

• Brand Name: BARRX 360 CLASSIC SIZING BALLOON
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17002046
• MDR Text Key: 315924965
• Report Number: 17002046
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 64082
• Device Lot Number: B000002147
• 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: 05/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1