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

Catalog Number	D132705
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Thrombosis/Thrombus (4440); Pericarditis (4448)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure under a bwi sponsored clinical trial with a thermocool smarttouch sf catheter.Patient received index cardiac ablation on (b)(6) 2025.On (b)(6) 2025, patient experienced ¿pericarditis¿ (adverse event (ae) # 1) categorized as moderate and not serious.Relationship to study device is ¿not related¿ and relationship to the index study procedure is ¿causal relationship¿.The outcome is ¿recovering/resolving.¿ intervention was ¿medication and tte (transthoracic echocardiography).¿ on (b)(6) 2025, patient experienced ¿partial occlusive deep venous thrombosis right leg¿ (ae# 2) categorized as moderate and not serious.Relationship to study device is ¿not related¿ and relationship to the index study procedure is ¿causal relationship.¿ the outcome is ¿recovering/resolving.¿ intervention was ¿medication and duplex echo groin.¿ on (b)(6) 2025, patient experienced ¿bilateral lung emboles¿ (ae# 3) categorized as severe and serious as defined by prolonged hospitalization.The patient was admitted on (b)(6) 2025 and was discharged on (b)(6) 2025.Relationship to study device is ¿not related¿ and relationship to the index study procedure is ¿causal relationship.¿ the event was ¿expected/anticipated.¿ the outcome is ¿recovering/resolving.¿ intervention was ¿medication.¿ on (b)(6) 2025, patient experienced ¿blurry vision left eye¿ (ae# 4) categorized as moderate and not serious.Relationship to study device is ¿not related¿ and relationship to the index study procedure is ¿causal relationship.¿ the outcome is ¿recovered/resolved.¿ intervention was ¿medication.¿ the events of bilateral lung embolism and partial occlusive deep venous thrombosis right leg are mdr reportable.However, pericarditis was considered not serious, therefore it is not mdr reportable.
Additional Manufacturer Narrative
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.No: (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 31549996m and no internal action related to the complaint was 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
For adverse event term pericarditis (ae#1): end date value of "15-sep-2025" has been changed to "26 aug 2025".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
On 17-dec-2025, updated information was received as follows: for adverse event term: pericarditis (ae#1) - the outcome is ¿resolved¿ with an end date of (b)(6) 2025.For adverse event term: partial occlusive deep venous thrombosis right leg (ae#2) - the outcome is ¿resolved¿ with an end date of (b)(6) 2025.For adverse event term: bilateral lung emboles (ae#3) - the outcome is ¿resolved¿ with an end date of (b)(6) 2025.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 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23019189
• Report Number: 2029046-2025-03084
• Device Sequence Number: 15908694
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(17)280421(10)31549996M
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/17/2026

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: D132705
• Device Lot Number: 31549996M
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 12/17/2025; 01/20/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/08/2025; 01/14/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM VERSION 8; GENERATOR:SMARTABLATE; PENTARAY NAV ECO 7FR, F, 2-6-2
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female