MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCJH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.A manufacturing record evaluation was performed for the finished device 30157433m number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During ablation of the left atrial appendage, a steam pop occurred.Cardiac tamponade was confirmed by intracardiac echocardiography (ice).Pericardiocentesis was performed to remove 865 cc of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.Extended hospitalization was not required.Patient¿s outcome is fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is related to the patient condition and the steam pop.Transseptal puncture was performed using a sl1 transseptal needle.An impedance max error message was observed on the generator.The force visualization features used included graph, visitag, dashboard and vector.The parameters for stability used with the visitag module were 3 mm for 5 sec, and tag size 2 mm, no additional filters were used.The color option used prospectively was force and time.The steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.The high impedance issue was assessed as not reportable as the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY 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: 9183050
• Report Number: 2029046-2019-03750
• Device Sequence Number: 19535784
• Product Code: OAD
• UDI-Device Identifier: 10846835000573
• UDI-Public: 10846835000573
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 12/10/2021
• Device Catalogue Number: NI75TCJH
• Device Lot Number: 30157433M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/12/2019
• 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