MAUDE Adverse Event Report: Biosense Webster Inc THERMOCOOL SMARTTOUCH SF; Cardiac Ablation Percutaneous Catheter

Catalog Number	D134805
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure and the patient experienced pericardial effusion that required pericardiocentesis.First, unrelated to the event, it was reported that an optrell catheter had a black distal electrode and was not creating a matrix.The catheter was disconnected and reconnected, but the issue remained.The catheter cable was replaced, but the issue remained.The signal processing unit (spu) was disconnected and reconnected, but the issue remained.The spu was rebooted, but the issue remained.The catheter was replaced, and the problem was resolved.The case continued.The reported mapping issue with the optrell catheter is not considered to be a reportable issue as the potential risk that it could cause or contribute to a serious injury or death is remote.Then it was reported that a pericardial effusion was noticed on ultrasound intracardiac echocardiography (ice) catheter at the time the patient was complaining of chest pain.The effusion was confirmed with x-ray, ultrasound, and blood pressure readings.A pericardiocentesis was performed on the patient.The patient's last known status was stable.Multiple attempts have been made to gain clarification and additional information about this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
Additional Manufacturer Narrative
On 23-jul-2026, 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.Manufacturer's ref.#: (b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50071308
• Report Number: 3013300026-2026-02430
• Device Sequence Number: 13352563
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(17)290316(10)31889191L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial,Followup

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: D134805
• Device Lot Number: 31889191L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown