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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone : (b)(6).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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced pericardial effusion.After pulmonary vein isolation (pvi) and cavotricuspid ishmus (cti) were performed, it was confirmed that the patient¿s blood pressure decreased, and pericardial effusion was confirmed by echocardiography.The timing of the discovery was two-and-a-half hours after use of smart touch sf catheter, after cavotricuspid ishmus (cti) block line was ablated.The amount of pericardial effusion was small, so drainage could not be performed.The patient was observed in the catheter room for about 20 minutes and did not see a significant decrease in blood pressure.The patient was discharged from the catheter room and transferred to the icu for observation.Atrial septal puncture was performed with the rf (radiofrequency) needle, and ablation was performed before pericardial effusion or tamponade was confirmed.The patient was under observation post-procedure.The patient's condition improved.

Manufacturer Narrative

On (b)(6) 2023, bwi received additional information indicating that the patient required extended hospitalization a few days for observation and blood pressure monitoring.The patient had been discharged from the hospital.The "is hospitalization initial/prolonged" was selected in section b.The physician's identity has been updated in section e1.Smartablate generator has been added to the concomitant products section.On oct-25-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: the product 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.A manufacturing record evaluation was performed for the finished device 31095583l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The physician mentioned it was not related to product malfunction.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, 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.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 BI-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: 17918074
• MDR Text Key: 325444472
• Report Number: 2029046-2023-02294
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31095583L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR; UNSPECIFIED RF NEEDLE
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female