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

Catalog Number	D134801
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number 31404792l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).
Event or Problem Description
The report indicated after pvi/svci (pulmonary vein isolation / superior vena cava isolation) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, the patient experienced blood pressure decrease, pericardial effusion/cardiac tamponade initially treated with medication and then drainage.After the catheters were removed from the patient¿s cardiac cavity, it was confirmed that the patient¿s blood pressure decreased (about 60mmhg, 60 bpm).Noradrenaline was administered but the patient¿s condition was not changed.Pericardial effusion was confirmed by body surface echocardiography.After pericardial drainage was performed, the blood pressure increased, and the patient left the room.While the blood pressure was decreasing, the patient woke up from sedation, initiated spontaneous breathing, and was responsive.Investigation is ongoing regarding the progress and extended hospitalization.Since the event occurred after removal of the catheters, the used catheters were smart touch sf catheter, octaray, soundstar, and all were discarded.Also, a beeat catheter was used in the coronary sinus (cs).Physician assessment of the health hazard was non-serious (moderate/minor).The physician's opinions on the relationship between the event and the product there was a possibility of injury when the cs catheter (beeat) was removed from the patient¿s body.No abnormalities observed prior or after used of the devices.No extended hospitalization.Coloring settings for visitag was tag index, and visitag additional filters was fot (force over time).The outcome of the adverse event was fully recovered (no residual effects).The patient has been discharged from the hospital.The discharged date was unknown.The patient did not require cardiac surgery.No relevant rests/laboratory data reported.During the procedure, one catheter was used for each.No evidence of steam pop.The procedural act (activated clotting time) was 350 seconds over.Monitoring every 5 to 15 minutes.Transseptal puncture site performed during the procedure was one with two sheaths and transeptal puncture was performed with a rf (radiofrequency) needle (japan lifeline).Flow settings for irrigation was pre-1sec, and post-1sec.The first soundstar catheter had magnetic sensor error occurred.Reconnected the catheter, but the issue did not improve.Sound star eco catheter was replaced.The second soundstar catheter image was not displayed.There were no issues with the recognition of the catheter, when the catheter was removed from the patient¿s body.¿out of mapping range¿ occurred.The team reconnected the catheter and replaced the swift link, but the issue did not improve.Sound star eco catheter was replaced.The third catheter was used without any issues.The ultrasound machine screen was displayed on carto3 without any issues.The procedure was completed without patient's consequence.
Additional Manufacturer Narrative
Per internal review on 24-jun-2025, it was determined that no surgical intervention occurred, therefore the h6 health effect: impact cod for "surgical intervention" (f19) no longer applies.The code has now been replaced with "recognised device or procedural complication" (f15).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
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22136178
• Report Number: 2029046-2025-01798
• Device Sequence Number: 18231194
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)270827(10)31404792L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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 Catalogue Number: D134801
• Device Lot Number: 31404792L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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: OCTA, STD, 48P, 2-2-2-2-2, D-CURVE; RF NEEDLE; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN); SOUNDSTAR ECO SMS 8F CATHETER; SOUNDSTAR ECO SMS 8F CATHETER; SOUNDSTAR ECO SMS 8F CATHETER; UNK CS CATHETER (BEEAT); UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Race: Asian