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	Cardiac Perforation (2513)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a redo pvi (pulmonary vein isolation) ablation with a thermocool smarttouch and the patient experienced cardiac perforation that required pericardiocentesis and surgical intervention.It was reported that the procedure went quite well at the beginning.For the medical team, "it seemed like a bit of struggling" going to the la (left atrium) after the transseptal puncture (1 puncture two catheters through the same hole).After some some minutes the physician managed to go to the la with both catheters.Everything seemed fine and after the map the ablation started at the positions where the veins were still open.After 11 ablation points, the nurses and physician recognized a drop in the blood pressure and did ultrasound (tte - transthoracic echocardiogram) which showed a tamponade.Epicardial puncture was performed immediately and medication against heparin (had been given before in normal workflow) was given.The blood which was sucked out of the epicardial volume was reintroduced.Since the hole didn¿t close by itself, a heart surgeon had to come to open the chest and close the holes.She found 2 holes to close which where at the roof of the la next to lspv (left superior pulmonary vein) and in the pulmonary artery.After the surgeon was done, the patient was stable and brought to intensive care, where he was under medical supervision and was stable.Patient required extended hospitalization due to surgery.Reviewing the case on carto didn¿t show any failure in workflow of the physician or performance of the catheter.It was reported that the event occurred probably during transseptal or when going to the left with the ablation catheter.It was recognized, however, during ablation, at the 11 point.
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 number lot 31687632m and no internal actions related to the complaint were found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.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
On 11-may-2026, bwi received additional information regarding the event.Patient received a repeat cardiac ablation on (b)(6) 2026.On (b)(6) 2026, patient experienced cardiac tamponade categorized as severe and serious (defined by life-threatening illness or injury, medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function).The patient was hospitalized with an admission date of (b)(6) 2026 and a discharge date of (b)(6) 2026.Relationship of the tamponade to the study device (thermocool smarttouch d133602) was deemed as possible and the relationship to the repeat study procedure was also deemed as possible.The adverse event was anticipated.The outcome is resolved with an end date of (b)(6) 2026.Intervention was surgery (thoracotomy).Additionally, section a2 of this supplemental report has been updated with the patient's age (78 years old).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: 24734959
• Report Number: 2029046-2026-01024
• Device Sequence Number: 18463262
• Product Code: LPB
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 31687632M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White