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 Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Deformity of the ep catheter occurred when one of the wires at the tip broke while in the patient.There was no harm to the patient and the catheter was exchanged without incident.

• 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: 13117671
• MDR Text Key: 282974444
• Report Number: 13117671
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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: 30259146M
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other