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

Model Number	D134703
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 10-jan-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 a male patient underwent an atrial flutter left (l-afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that during a left-sided atrial flutter case, a pericardial effusion was noticed in the patient.They reported that a steam pop was noticed in the patient, initially in the distal left atrial appendage.The pericardial effusion was discovered on intracardiac echocardiography (ice), and the patient's blood pressure then dropped.The medical intervention provided to the patient was a pericardiocentesis, and about 355cc of fluid was aspirated from the patient.The patient is in stable condition.Additional information was received indicating the adverse event was discovered during use of biosense webster products, during the ablation phase.The physician¿s opinion on the cause of this adverse event was reported as a bwi product malfunction.Intervention included pericardiocentesis and blood was given.The outcome of the adverse event was reported as fully recovered.Patient required extended hospitalization because of the adverse event as a drain left in overnight and stayed in the intensive care unit (icu).A baylis standard c0 transseptal needle was used for the transseptal puncture performed.Ablation had already been performed prior to noting the pericardial effusion.There was evidence of steam pop, tactile feedback from catheter during steam pop per physician.The steam pop occurred during the ablation of the laa.The flow setting for the irrigated catheter used was 15ml/min.Correct catheter settings was selected on the smartablate generator and the pump was not switching 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 and vector.Parameters for stability for the visitag module used were 3mm for 5 seconds; tag size 2mm.No additional filter used with the visitag.Color options used prospectively was ablation index.Generator parameters used was power control; temperature cut off @ 40 degrees; power cut off @ 47w.The noted temperature, impedance and power was temperature 22-24 degrees; impedance 90-110 ohms; power 47w.The length (minutes and seconds) of the ablation session when the steam pop occurred was 1 minute and 19 seconds.No errors reported by the biosense webster systems.
Additional Manufacturer Narrative
It was reported that a male patient underwent an atrial flutter left (l-afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that during a left-sided atrial flutter case, a pericardial effusion was noticed in the patient.They reported that a steam pop was noticed in the patient, initially in the distal left atrial appendage.The pericardial effusion was discovered on intracardiac echocardiography (ice), and the patient's blood pressure then dropped.The medical intervention provided to the patient was a pericardiocentesis, and about 355cc of fluid was aspirated from the patient.The patient is in stable condition.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.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.The root cause of the adverse event remains unknown.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 instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.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 ref.# (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: 16153979
• Report Number: 2029046-2023-00086
• Device Sequence Number: 7562698
• 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): 02/16/2023

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: 09/15/2025
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30897586L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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 STANDARD C0 TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNKNOWN PUMP
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG