MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D134802
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).
Event or Problem Description
It was reported that an 82 year-old-female (weight reported as ¿very small¿) underwent an idiopathic ventricular tachycardia (idvt) - left ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported by the bwi representative that during a left sided premature ventricular contraction (pvc) procedure the patients pressure dropped and it was observed by intra-cardiac ultrasound that the patient developed a pericardial effusion.A pericardiocentesis was performed in which 200 cc's was removed from the pericardial space.The patient was stabilized and transferred to the critical care unit (ccu) for observation.The patient had 2 extra days in the hospital because of the pericardial drain.Additional information received indicated the physician¿s opinion on the cause of this adverse event is that it was procedure related.The physician believes it was caused by the procedure, not by anything catheter related.Outcome from the adverse event was reported as fully recovered (no residual effects).A smartablate generator was used during the procedure with the correct catheter settings selected.The flow setting for the irrigated catheter was standard stsf settings of 2, 8-15cc/min.Ablation was performed (1 burn) prior to noting the cardiac tamponade.There is no evidence of steam pop.Event occurred during the ablation phase.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used were graph, dashboard, vector and visitag.Parameters for stability for the visitag module used was standard settings, range 3mm, time 3sec, force over time (fot) 3grams 25% of time respiratory trained.No additional filter used with the visitag.Color options used was force time intervel (fti).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15830496
• Report Number: 2029046-2022-02869
• Device Sequence Number: 5284361
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: D134802
• Device Catalogue Number: D134802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNKNOWN PUMP
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female