MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710FJ282RTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/14/2019
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a male patient ((b)(6)) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a webster ® cs catheter with ez steer¿ technology and suffered cardiac tamponade requiring pericardiocentesis.During the mapping phase the intracardiac echocardiography (ice) catheter was positioned to visualize the thermocool® smart touch® sf uni-directional navigation catheter ablation catheter in the left ventricle (lv), at that time, cardiac tamponade was confirmed by echo.Pericardiocentesis was performed to remove 237 cc of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.The patient kept overnight and was discharged the next day.Patient¿s outcome is fully recovered.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, he believed it occurred either during the transseptal puncture or cs catheter placement.There was no evidence of steam pop nor change in the impedance value throughout the 2 ablations performed.The thermocool® smart touch® sf uni-directional navigation catheter was set per normal smartablate settings: 2cc/min during mapping, 8cc/min when applying 30w and less and 15cc/min when applying 31w and greater.No error messages were observed on any bwi equipment during the procedure.The thermocool® smart touch® sf uni-directional navigation catheter was not in close proximity to another catheter and it was zeroed after the initial warm-up phase post catheter connection to the carto® 3 piu.The carto® 3 system did not indicate to re-zero the catheter.Based on the information available, it has been determined that the event will be reported under both bwi products, the thermocool® smart touch® sf uni-directional navigation catheter and the webster ® cs catheter with ez steer¿ technology as both were in use at the time of the adverse event.As such, biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019- 03227 for product code d134702 (thermocool® smart touch® sf uni-directional navigation catheter); this mfr # for product code bd710fj282rts (webster ® cs catheter with ez steer¿ technology).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8670280
• Report Number: 2029046-2019-03228
• Device Sequence Number: 263552
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: 10846835002430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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 Catalogue Number: BD710FJ282RTS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/05/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 98