MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. EZ STEER NAV DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BN7TCDF8L
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Steam pop occurred during rf cti (radiofrequency cavotricuspid isthmus) ablation.Patient developed acute hemopericardium with tamponade requiring emergent pericardiocentesis, taken to or (operating room) for repair of right atrial perforation.

• Brand Name: EZ STEER NAV DS
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 12922833
• Report Number: 12922833
• Device Sequence Number: 12001392
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: (01)10846835003000(17)240927(10)30654241
• 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): 11/29/2021
• Report Date (Section F): 11/29/2021

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: BN7TCDF8L
• Device Catalogue Number: BN7TCDF8L
• Device Lot Number: 30654241
• 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: 12/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2021
• 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: Female
• Patient Race: White
• Date Report Sent to FDA: 11/29/2021