MAUDE Adverse Event Report: BIOSENSE WEBSTER THERMACOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER; RFA CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Embolus (1830)

Event Date 04/15/2019

Event Type  Injury  

Event Description

Pt with history of atrial fibrillation had radiofrequency ablation under general anesthesia in electrophysiology lab on (b)(6) 2019.Pt later had expressive aphasia post procedure; mri confirmed embolic stroke.Tip of the rfa catheter later reported to have extensive charring, concern (b)(6) 2019 re charring and outcome.

• Brand Name: THERMACOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER
• Type of Device: RFA CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER; 33 technology drive; irvine CA 92618
• MDR Report Key: 8651143
• MDR Text Key: 146424113
• Report Number: 8651143
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2019
• Distributor Facility Aware Date: 05/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 100