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

Catalog Number	D134701
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067); Cardiogenic Shock (2262); Cardiac Perforation (2513)
Date of Event	02/25/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
On 18-mar-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.Date of death was not provided, as such, best estimate of (b)(6) 2026 was added to field b 2.Date of death (b)(6) 2026 is one week after the ablation procedure.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).
Event or Problem Description
It was reported that a patient underwent a left atrial flutter (l-afl) ablation procedure with a thermocool smarttouch sf and the patient experienced cardiac perforation that required pericardiocentesis, surgical repair, ecmo and hemodialysis.Ultimately the patient died.During ablation a steam pop occurred using 35 watts and a contact force of 43g at the point in question.The patient experienced a pericardial effusion.Patient required a pericardial puncture and reinfusion but the pericardial effusion did not resolve on its own and therefore the patient was transported to another hospital (universitätsklinikum frankfurt) for thoracotomy and they found right ventricle (rv) perforation and it was repaired surgically.The patient's condition worsened and the patient was on ecmo (extracorporeal membrane oxygenation) and hemodialysis.The patient became septic 1 week post event.Then it was reported that the patient died.The physician's opinion on the adverse event was that force was too high during ablation and perforation was found in the rv.It was reported that there was a small not audible steam pop in left atrium (la) anterior wall that could correlate with pericardial effusion timing, but does not correlate with the location of the perforation.It was also reported that there was a second steam pop in ra (right atrium) during cti that could correlate with perforation location in rv, but occurred just about 30s prior to massive pericardial effusion so per the physician, the timing would not fit.The physician is sure that he did not dislocate to the right ventricle during ablation.During the procedure the norm target values for act were around 330, after protamin application it was 180.39 ablations were performed (radiofrequency), 19 within pulmonary veins (4 anterior rspv, 10 posterior lpv; 5 anterior lpv ridge) and 20 outside pulmonary veins (12 anterior la wall; 3 la roof; ra 5 cti).Irrigation during ablation was 15 ml/min.
Additional Manufacturer Narrative
On 27-mar-2026, additional information about the patient and event were received.It was reported the date of death was (b)(6) 2026.The cause of death was multiorgan failure following cardiogenic and hemorrhagic shock, occurring after urgent cardiac surgery for cardiac tamponade subsequent to biatrial ablation.The patient underwent repeat mitral valve surgery and redo catheter ablation for atypical atrial flutter.During left atrial linear ablation, a subtle steam pop occurred, which was followed by the development of acute cardiac tamponade.Pericardial drainage was technically challenging due to extensive epicardial adhesions, but initial hemodynamic stabilization was achieved.Subsequently, the patient developed recurrent bleeding, necessitating transfer to emergency cardiac surgery.The patient was placed on extracorporeal membrane oxygenation (ecmo) and underwent urgent cardiac and abdominal surgery because of ongoing cardiac and hepatic bleeding, which was suspected to be related to an acquired disseminated coagulopathy following the difficult subxiphoid pericardial puncture.Despite prolonged ecmo support, the postoperative course was complicated by progressive multiorgan failure and sepsis, ultimately resulting in death.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.The device evaluation was completed on 25-mar-2026.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 batch number, and no internal actions were identified.The force issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The carto® 3 system instructions for use (ifu) contain the following information: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.The steam pop reported was not confirmed during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The ngen generator user manual contains the following information: when the tissue is exposed to excessively high rf current densities, the tissue fluid boils so rapidly that the resulting steam and higher intracellular pressure cause the cell membrane to erupt.If this process occurs suddenly (superheating), it is perceptible as a steam explosion.Since this phenomenon is audible in certain cases and under some circumstances can be felt at the catheter handle, it is also known as "pop." in extreme cases, this can lead to undesirable effects such as perforations and resulting tamponade.Using the power settings recommended in the instructions for use for the catheter and ensuring sufficient contact between the ablation electrode and the myocardial wall should prevent this pop effect.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.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24656444
• Report Number: 2029046-2026-00938
• Device Sequence Number: 9289242
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)281117(10)31798173L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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: D134701
• Device Lot Number: 31798173L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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; Hospitalization; Death
• Patient Sex: Unknown