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

Catalog Number	D134701
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 24-nov-2025, 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.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
During a left idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool smarttouch sf and the patient experienced blood pressure of 72/51 and pericardial effusion treated with pericardiocentesis.It was reported that there was a pericardial effusion reported during premature ventricular contraction (pvc) ablation using the carto 3 system and the thermocool smarttouch sf.While burning in the anterior lateral path for a while, they did not notice a change in force or impedance.The physician then noticed there was a change in the patient¿s non-invasive blood pressure.The blood pressure was 72/51.A pericardiocentesis was performed and 40 ml of fluid was removed.The fluid was given back to the patient via a central line.The patient¿s blood pressure improved and the effusion "did not come back".The patient is stable, and the drainage tube was removed.The patient left the electrophysiology (ep) lab and was transported to the cardiovascular outpatient unit.The patient required extended hospitalization because of staying overnight for observation although no extra intervention occurred.The outcome of the adverse event was fully recovered (no residual effects).The energy source used when the adverse event occurred was rf.One transseptal puncture site was performed during the procedure.The number of performed ablations was 11.All burns were around the anterolateral papillary muscle in the left ventricle.
Additional Manufacturer Narrative
During a left idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool smarttouch sf and the patient experienced blood pressure of 72/51 and pericardial effusion treated with pericardiocentesis.Device evaluation details: the product was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and revision of all features were performed following johnson & johnson medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed.No magnetic, force, deflection, or electrical issues were found during the product investigation.However, during the test, high temperature was displayed and the device was found occluded.Further investigation revealed blood residues occluding the irrigation holes contributing to the temperature issue detected.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.The potential cause of the high temperature results and blood occlusion observed during the test could be related to the usage of the device during the analysis; however, this cannot be conclusively determined and this issue was not related to the reported event.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: dome (g04046) were selected as related to the high temperature and occlusion identified by bwi pal.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the reported adverse event issue 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: 23647313
• Report Number: 2029046-2025-03908
• Device Sequence Number: 4823281
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)280729(10)31710382L
• 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

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: 31710382L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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.; NGEN PUMP, US CONFIGURATION.; NGEN RF GENERATOR, US.; STRIKER REPROCESSED SOUNDSTAR.; UNKNOWN DRAINAGE TUBE.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White