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

Model Number	BNI35BDH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30385946l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a cardiac ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.After the catheter was inserted, mapping of the right ventricle outflow tract (rvot) was performed.After that, cardiac tamponade was diagnosed and pericardiocentesis was done to drain the fluid.Patient¿s vitals then became stable, and the ablation procedure could be safely finished.No ablation had been conducted before the cardiac tamponade occurred.The patient was followed up after the procedure.There¿s no report of prolonged hospitalization.Patient¿s condition improved.The physician does not know what the cause of the issue was but commented it was not related to the bwi product.No bwi product malfunction was reported.

• 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: 11713945
• Report Number: 2029046-2021-00655
• Device Sequence Number: 3766039
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: 10846835003154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 05/25/2023
• Device Model Number: BNI35BDH
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 30385946L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/23/2021
• 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