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

Model Number BN7TCDF8L

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 11/19/2021

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 281663636
• Report Number: 12922833
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: (01)10846835003000(17)240927(10)30654241
• 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: 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
• Device Operator: 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
• Date Report Sent to FDA: 11/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Female
• Patient Race: White