MAUDE Adverse Event Report: Biosense Webster Inc Webster CS; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	BD710DF282RTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Ez steer deca catheter failed related to pin malfunction./catheter removed and exchanged with inquiry deca catheter.No pt harm.

• Brand Name: Webster CS
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive; suite 200; irvine CA 92618
• MDR Report Key: 50818203
• Report Number: 50818203
• Device Sequence Number: 21494817
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: (01)10846835002416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 09/09/2026
• Report Date (Section F): 09/09/2026

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: BD710DF282RTS
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: F100009328
• 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: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 181 LB
• Date Report Sent to FDA: 09/09/2026