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

Catalog Number	D134702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/24/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).
Event or Problem Description
It was reported that a male patient who underwent an ablation procedure for atrial fibrillation with a thermocool smart touch sf catheter experienced a cardiac tamponade requiring pericardiocentesis.After the ablation phase of the procedure, the physician checked for any pericardial effusion and was able to confirm one using intracardiac echocardiography and noting a drop in the patient's blood pressure.As a result, a pericardiocentesis was performed.Sometime after the intervention occurred, the patient expired.Per the physician, the harm may have occurred late in the procedure while ablating the cavotricuspid isthmus line with the smart touch catheter.No steam pops were noted during the case.
Additional Manufacturer Narrative
On 25-may-2026, the product investigation was completed.D4 lot number was updated to 31828472l d4 primary udi number has been updated to: (b)(4).It was reported that a male patient who underwent an ablation procedure for atrial fibrillation with a thermocool smart touch sf catheter experienced a cardiac tamponade requiring pericardiocentesis.After the ablation phase of the procedure, the physician checked for any pericardial effusion, and was able to confirm one using intracardiac echocardiography and noting a drop in the patient's blood pressure.As a result, a pericardiocentesis was performed.Sometime after the intervention occurred, the patient expired.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and revision of all device features were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to carto 3 system and an ablation cycle was performed, no force, magnetic, noise, temperature or impedance issues were found.Additionally, device was deflected and irrigated during the test and no issues were observed.A manufacturing record evaluation was performed for the finished device 31828472l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The instructions for use (ifu) states the following recommendations: when using the catheter with conventional systems (such as fluoroscopy or intracardiac echocardiography), with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement should be done under direct imaging guidance.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The 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: 25234609
• Report Number: 2029046-2026-01632
• Device Sequence Number: 16041665
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: (01)10846835009781(17)290127(10)31828472L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: D134702
• Device Lot Number: 31828472L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• 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: Required Intervention; Death; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male