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

Catalog Number	D134804
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch sf catheter and the patient experienced drop in blood pressure and pericardial effusion that was attempted to be treated with pericardiocentesis, but the physician had issues or difficulty placing the wire "to get the drain going".The patient was then admitted to the operating room (or).The patient required extended hospitalization and discharged from the hospital a few days later.The report indicated that during the case, a pericardial effusion was noticed in the patient.After they had completed ablation on the anterior mitral line, with the thermocool smarttouch sf catheter, the anesthesiologist noticed a drop in blood pressure on the patient about 10 minutes later.The soundstar catheter was re-inserted back into the body, and a pericardial effusion was then discovered on intracardiac echocardiography (ice).They called in a "stat" echo.The physician had issues or difficulty placing the wire "to get the drain going" for a pericardiocentesis.The patient was then admitted to the or.The last patient¿s status was that they were in stable condition.Additional information received indicated that the physician¿s opinion on the cause of this adverse event was that the definite cause is unknown; however, the physician assumes it had something connected to the radiofrequency (rf) section of the case.The patient¿s outcome from the adverse event was reported as recovered.The patient required extended hospitalization because of normal recovery time post or procedure; the patient was discharged from the hospital a few days later.The afib procedure was aborted once the effusion was observed.The transseptal puncture was performed with versacross and/rf wire.The event occurred during ablation phases (suspected).The flow setting was set to thermocool smarttouch sf catheter default.
Additional Manufacturer Narrative
On 15-jan-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.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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).
Additional Manufacturer Narrative
On 14-jan-2026, additional information was received indicating the patient required cardiac surgery to drain the pericardial effusion (pe), and the perforation location is unknown.The activated clotting time (act) before procedure was 133, and the act during procedure was 1330-360.The radio frequency (rf) catheter was exchanged one time.There were no sheath exchanges.The boston pulsed field ablation (pfa) catheter was exchanged multiple times throughout the procedure with an octaray mapping catheter.One transseptal puncture site was performed during the procedure.23 rf ablations, and unknown total of pfa ablations.Pfa ablations for veins, posterior wall, and initial anterior mitral lesions.Rf ablations to reinforce anterior mitral line.Pfa ablations for posterior wall unknown, 12 pfa lesions on the anterior mitral line.Prior to noting the pericardial effusion, rf and pf ablations were performed.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch sf catheter and the patient experienced drop in blood pressure and pericardial effusion that was treated with surgical intervention and extended hospitalization.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 force test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to the carto 3 system and no errors were observed.The force feature of the device was evaluated and the force values and the vector were observed within specifications.No force issues were observed.During the test no irrigation, deflection or noise issues were observed.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint were identified.No issues were observed on the device during the analysis.The root cause of the adverse event reported by the customer remains unknown.The instructions for use (ifu) contain the following information: careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.As part of johnson and johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Note: through device evaluation, the lot number was verified to be 31710275l.This information has been added to field d4.Lot.Additionally, based on the availability of the lot number, the manufacture and expiration dates and full primary udi number were also made available.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: 24147979
• Report Number: 2029046-2026-00285
• Device Sequence Number: 12983535
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(17)280812(10)31710275L
• 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,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: D134804
• Device Lot Number: 31710275L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/18/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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; REPROCESSED WEBSTER CS CATHETER; REPROCESSED WEBSTER CS CATHETER; SMARTABLATE GENERATOR KIT-US; UNK_FARAPULSE¿ SYSTEM; UNK_SMARTABLATE GENERATOR; UNK_SOUNDSTAR CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White