MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF CARTO 3,F-J,TC; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35FJCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/24/2019
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.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture ref no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ischemic ventricular tachycardia ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.After mapping and ablating from the retrograde aortic approach, the physician obtained transseptal access to continue.At the end of the procedure, a drop in blood pressure was noticed.Cardiac tamponade was confirmed using intracardiac echocardiogram.A pericardiocentesis was performed removing 220 cc of fluid from around the patient's heart.Patient was left with a drain in place.The patient's blood pressure stabilized, and they were transferred to the intensive care unit.The patient condition improved.The physician did not provide a causality for the event.A transseptal puncture was performed with an unknown needle.The flow setting was set to standard settings.There was no evidence of steam pop during the procedure.

• Brand Name: THERMOCOOL SF CARTO 3,F-J,TC
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9345866
• Report Number: 2029046-2019-03903
• Device Sequence Number: 13992607
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: 10846835003260
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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): 10/24/2019

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 Catalogue Number: BNI35FJCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/20/2019
• 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
• Patient Age: 74 YR