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

Model Number	NI75TCFH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/27/2019
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.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.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 male patient underwent an ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During all the procedure, the patient¿s blood pressure was considerably low.Post-ablation phase, at the end of the procedure, cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of blood from the pericardial space.Surgical intervention was not required.Extended hospitalization was required as a result of the adverse event.Patient¿s outcome was fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was both procedure and patient condition related.No biosense webster inc.(bwi) product malfunctions were reported.Transseptal puncture was performed with mullins and brokenbrough transseptal needle from medtronic.There was no evidence of steam pop during the ablation.The flow was set at low flow: 2 ml/min and high flow: 30 ml/min.No error messages were observed on any bwi equipment.The force visualization features used included dashboard, vector and visitag.The parameters for stability used with the visitag module were 3 mm 3s 25% time, size 3.The color option used prospectively was ablation index.
Additional Manufacturer Narrative
During an internal review on (b)(6)2020 , it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with (b)(6)2022 and section h4 manufacture date has been updated with (b)(6)2019.Manufacture reference no: (b)(4).

• 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: 9107886
• Report Number: 2029046-2019-03682
• Device Sequence Number: 3242606
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• 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): 08/28/2019

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: 01/10/2022
• Device Model Number: NI75TCFH
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30162550M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 05/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; MEDTRONIC BROKENBROUGH TRANSSEPTAL NEEDLE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention