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

Catalog Number D134701

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure that included thermocool® smart touch® sf uni-directional navigation catheter.The patient experienced cardiac tamponade that required pericardiocentesis and surgery.During the ablation, the impedance rose above the cut-off within a few seconds and the smart ablate switched off.A few minutes later the patient suffered a hemodynamic collapse.An ultrasound examination of the heart was performed.It was found that the patient had a pericardial effusion.The pericardium was then punctured and the electrophysiological examination stopped.Surgery was delayed by 40 minutes and the procedure was not successfully completed.Additional information was received on 30-aug-2023.Procedure was aborted because of the adverse event.The patient needed surgery after the tamponade and has a patch on the heart.Patient has been reported alive and stable.Additional information was received on 08-sep-2023.Customer does not think biosense webster, inc.Products were the cause of the adverse event but possibly the procedure and patient condition.Intervention was medication as first attempt to increase blood pressure.Because of the moderate success of this, a pericardial puncture was carried out.Since the bleeding would not stop, it was decided to finally treat the patient with cardiac surgery.Patient was under general anesthesia approximately 2 hours.The patient made a full recovery; however, the patient did have heart surgery.Patient required extended hospitalization for heart surgery.Force visualization features were graph, dashboard, vector and visitag.Parameters for visitag stability were 5mm range and 4sec time.Additional filter used with visitag were respiration adjustment, force over time and tag index.Color option was ablation index.Transseptal performed with a brk needle from sjm 98 cm via vizigo sheath.Flow setting on irrigated catheter was 2 ml low flow and 15 ml high flow.Correct catheter settings were selected on generator.Pump was switching from "low" to "high" flow.Prior to noting the cardiac tamponade, ablation was performed.No evidence of steam pop.Event occurred during the ablation phase.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The impedance issue was assessed as non mdr reportable.Since the user-defined cut-off was exceeded and ablation was stopped, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2023.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure that included thermocool® smart touch® sf uni-directional navigation catheter.During the ablation, the impedance rose above the cut-off within a few seconds and the smart ablate switched off.A few minutes later the patient suffered a hemodynamic collapse.An ultrasound examination of the heart was performed.It was found that the patient had a pericardial effusion.The pericardium was then punctured.The patient needed surgery after the tamponade and has a patch on the heart.The patient made a full recovery.Patient required extended hospitalization for the heart surgery.The investigation was completed on 23-oct-2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance test 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.The temperature and impedance test was performed and the device was found working correctly.No impedance issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.No malfunction was observed during the product analysis.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: 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: 17768526
• MDR Text Key: 323654367
• Report Number: 2029046-2023-02110
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134701
• Device Lot Number: 31089049L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ SMC; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; ST. JUDE MEDICAL BRK 98 CM NEEDLE; UNK PUMP
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male