MAUDE Adverse Event Report: BIOSENSE WEBSTER EZ STEER THERMOCOOL BIDIRECTIONAL EPS CATHETER

Model Number	STOCKERT
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
During a cardiac ablation, physician was unable to see electrical activity on ep med system.Cables were replaced, staff checked all the connections and eventually changed the ablation catheter with only slight improvement.Ultimately, they had to switch ablation generators.

• Brand Name: EZ STEER THERMOCOOL BIDIRECTIONAL EPS CATHETER
• Common Device Name: EZ STEER THERMOCOOL BIDIRECTIONAL EPS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER; diamond bar CA 91765
• MDR Report Key: 5532313
• Report Number: MW5061300
• Device Sequence Number: 10849537
• Product Code: LPB
• UDI-Device Identifier: 10846835002898
• UDI-Public: 10846835002898
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2016

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 Expiration Date: 09/30/2018
• Device Model Number: STOCKERT
• Device Catalogue Number: BDI756CFJRT
• Device Lot Number: 17333491M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66