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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter inserted and all electrodes went black during ablation.No information was transmittable to carto ((01) (b)(4)).New catheter utilized and issue resolved.No adverse harm to patient.Rep called in product.Catheter inserted, bad electrode, noisy signal (01)(b)(4).No adverse harm to pt.New catheter utilized w/o issues.Rep called in product.

• 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: 13659025
• Report Number: 13659025
• Device Sequence Number: 1905857
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: (01)10846835003000(20)22(17)241104(10)30670692M
• 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): 02/25/2022
• Report Date (Section F): 02/25/2022

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: 30670692M
• 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: 03/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2022
• 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: Male
• Patient Weight: 99 KG
• Patient Race: White
• Date Report Sent to FDA: 02/25/2022