MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BNI35BDCT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Component code of ¿appropriate term/code not available" represents "no findings available." the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported while the patient was in the recovery room after the procedure; the patient appeared very gray, pale, and her blood pressure dropped.The patient was taken back to the procedure room and the patient had an ultrasound that confirmed the patient had a pericardial effusion.Pericardiocentesis was performed.The patient was stable and was transferred to the cardiac intensive care unit for overnight observation.There was no report of extended hospitalization.Physician¿s causality opinion was not provided.Transseptal was performed with a brk needle (st.Jude).Ablation was performed before the event.There was no evidence of steam pop.Flow settings were used per the instructions for use guidelines.No error messages were observed on the biosense webster equipment during the procedure.

• Brand Name: THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10916287
• Report Number: 2029046-2020-01813
• Device Sequence Number: 4295422
• Product Code: LPB
• UDI-Device Identifier: 10846835003147
• UDI-Public: 10846835003147
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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 Model Number: BNI35BDCT
• Device Catalogue Number: BNI35BDCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/29/2020
• 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