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

Model Number	D131503
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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 (b)(6) male patient underwent a premature ventricular tachycardia (pvc)/ idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® sf nav uni-directional catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.During an pvc /ventricular tachycardia idiopathic case, a pericardial effusion was noticed.The pericardial effusion was discovered when they performed an ¿angiogram out the coronary sinus¿ and they watched as pericardial effusion continued to grow.The pericardial effusion was confirmed by ice.The medical intervention provided was "draining the fluid" and 120 cc of fluid was removed.The patient was reported to be in stable condition.The procedure continued successfully.The reporter stated that the cause of the pericardial effusion is unclear.Additional information: this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure.Intervention provided: the fluid was removed.Patient outcome of the adverse event: fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event.A transseptal puncture was not performed.Prior to noting ct ablation was performed in the left ventricle.No evidence of steam pop.The event occurred during mapping phase.Irrigated catheter was used in the event and the flow setting: 8ml/min up to 30 w ¿ 15 ml/min over 30 w.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used: graph, dashboard, vector, visitag with the visitag module parameters for stability were used: 2.5,3, 25, 3, tag size 2.No additional filter used with the visitag.Color options were used prospectively: fti.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• Brand Name: THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12292287
• Report Number: 2029046-2021-01298
• Device Sequence Number: 19785140
• Product Code: LPB
• UDI-Device Identifier: 10846835009293
• UDI-Public: 10846835009293
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• 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): 07/13/2021

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 Model Number: D131503
• Device Catalogue Number: D131503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/09/2021
• 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; DECANAV; SOUNDSTAR ECO; UNSPECIFIED GENERATOR; VISITAG MODULE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 60 YR