MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for atrial flutter with an ez steer¿ thermocool® nav bi-directional catheter and suffered a heart block av requiring a surgical intervention.During ablation, the patient went into complete heart block.Remainder of procedure was aborted.A permanent pacemaker was inserted.Patient did not require extended hospitalization as a result of the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s condition.

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7534330
• Report Number: 2029046-2018-01577
• Device Sequence Number: 13830926
• Product Code: OAD
• UDI-Device Identifier: 10846835003376
• UDI-Public: 10846835003376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• 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: Other; Required Intervention
• Patient Age: 55 YR