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

Catalog Number	D134703
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a persistent atrial fibrillation cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and patient experienced cardiac tamponade treated with a pericardiocentesis.During ablation, there were two steam pops during the procedure when performing ablation on the left side.There were no impedance spikes displayed on the carto 3 system.The procedure continued without troubleshooting.Pericardial effusion was noticed on the right side of the heart confirmed with intracardiac echocardiography (ice) during a post-check on the patient after the procedure was completed.The patient had no visible symptoms.The patient was reported to be in stable condition.Additional information was received.Transseptal was performed with baylis machine and versacross sheath, unknown serial number.Physician¿s opinion on the cause of this adverse event is patient condition.The patient outcome is fully recovered.Correct settings on devices and no error messages during the procedure.The patient stayed overnight.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation 12-jan-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported a patient underwent a persistent atrial fibrillation cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and patient experienced cardiac tamponade treated with a pericardiocentesis.During ablation, there were two steam pops during the procedure when performing ablation on the left side.The investigation was completed on 19-jan-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.An irrigation test was performed and the device was flushing correctly.No obstructed holes or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event is patient condition.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 18523168
• Report Number: 2029046-2024-00188
• Device Sequence Number: 20869561
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/09/2024

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: 05/18/2026
• Device Catalogue Number: D134703
• Device Lot Number: 31056813L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: BAYLIS MACHINE; SMARTABLATE GENERATOR KIT-US; UNK PUMP; UNK_CARTO 3; VERSACROSS SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 44 YR
• Patient Sex: Male