MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D132704
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The ablation catheter was placed in the body.The catheter was defective due to it producing extra stimulus noise, causing intermittent high impedance readings.The catheter was then removed from body and a new catheter was used.The cables were changed first.The procedure was carried out with no complications.

• Brand Name: THERMOCOOL SMARTTOUCH
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 10835598
• Report Number: 10835598
• Device Sequence Number: 17093519
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: (01)10846835009194(17)210701(10)30401573M
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 11/04/2020

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: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30401573M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88
• Date Report Sent to FDA: 11/04/2020