MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133602
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure during a bwi sponsored clinical trial with a thermocool smarttouch catheter and the patient experienced 3rd degree av block requiring a pacemaker and prolonged hospitalization.On (b)(6) 2025 start date, the patient received index cardiac ablation, and site awareness date of (b)(6) 2025, the patient experienced 3rd degree av block (ae# 1).During superventricular tachycardia (svt) ablation procedure, with thermocool smarttouch catheter, categorized as severe and serious, requiring in-patient or prolonged hospitalization, with an admission date of (b)(6) 2025 and discharged date of (b)(6) 2025.The event required medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function.The relationship to study device is not related.The relationship to the index study procedure is causal and the event is unexpected/unanticipated.The outcome is recovered/resolved with an end date of (b)(6) 2025.Intervention is surgery with a pacemaker.Date event first reported to be a serious adverse event (sae) was (b)(6) 2025.No steam pop reported.Computed tomography (ct) showed no thrombus on (b)(6) 2025.
Additional Manufacturer Narrative
A 1.Patient identifier: (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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device number lot 31724528m and no internal actions related to the complaint were found during the review.Since no device has been received for analysis, no product investigation could be performed, and the customer complaint cannot be confirmed.However, if the product is received in the future, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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).
Additional Manufacturer Narrative
Additional information received on 12-dec-2025 indicated that the adverse event started after superventricular tachycardia (svt) ablation procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information indicated that the event value has been changed from ¿unexpected/unanticipated" to "expected/anticipated".The primary adverse event (ae) is heart block.Correction to follow up report (b)(4): h6.Type of investigation was missing analysis of production records (b14).Therefore, h6.Type of investigation has been updated.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 SMARTTOUCH
• 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: 23711685
• Report Number: 2029046-2025-03997
• Device Sequence Number: 12989325
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)280807(10)31724528M
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2026

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: D133602
• Device Lot Number: 31724528M
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 01/13/2026; 02/09/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/06/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male