MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAVIGATION; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BNI75TCFJH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/01/2019
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.Since no lot number was provided, no manufacture record evaluation (mre) review could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a ez steer¿ thermocool® nav bi-directional catheter, and the patient suffered a cardiac tamponade.During the mapping phase, the patient had a cardiac tamponade.The physician solved the problem, and the patient was ok.It is unknown what intervention was performed.The patient required extended hospitalization of an extra day for monitoring.Physician¿s opinion on the cause of the event is that it was patient condition related.The irrigation was set for 2ml/min as this was mapping phase.There was no transseptal puncture performed.No ablation was performed.No steam pop was noticed prior to the event.
Additional Manufacturer Narrative
During an internal review on 5/5/2020, it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with 6/18/2021 and section h4 manufacture date has been updated with 6/9/2018.Manufacture reference no: (b)(4).

• Brand Name: EZ STEER THERMOCOOL NAVIGATION
• 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: 9585995
• Report Number: 2029046-2020-00082
• Device Sequence Number: 2696967
• Product Code: OAD
• UDI-Device Identifier: 10846835003376
• UDI-Public: 10846835003376
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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
• Device Expiration Date: 06/18/2021
• Device Model Number: BNI75TCFJH
• Device Catalogue Number: BNI75TCFJH
• Device Lot Number: 30070495M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: Life Threatening; Required Intervention