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 Tamponade (2226)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
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 31711448m and no internal action related to the complaint was 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.If the product is received at a later date, the investigation will be updated as applicable.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 patient underwent an atrial flutter right (r-afl) procedure with a thermocool smarttouch catheter and suffered a cardiac tamponade which required a pericardial puncture and then taken into surgery to stop the bleeding.During the ablation phase, while in the isthmus-caval tract (ict), the anesthesiologist noticed a drop in the patient's blood pressure.The doctor quickly suggested an ultrasound and noticed that there was a pericardial effusion.They had to perform a pericardial puncture to drain the blood and were able to remove a significant amount of blood to stabilize the patient.However, they were unable to stop the bleeding, so the patient had to be taken into surgery to stop the bleeding.The ablation on the ict was with 40w, power control, temperature cut off: 50 degrees, impedance cut off: 15 ohm/0.5segs.After this happened, they checked to see if any of the applications were faulty, if there were any force peak or impedance jump, but could not find anything unusual.The surgery was delayed due to the reported event for 50 minutes.The action taken was that the procedure was finished, but the procedure was not successfully completed.The patient was not part of a clinical study.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.

• 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: 23429979
• Report Number: 2029046-2025-03638
• Device Sequence Number: 13211121
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)280731(10)31711448M
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• 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
• Report Date (Section B): 10/30/2025

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: 31711448M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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: CARTO3 EXTERNAL REFPATCH 6PACK; DEF 6F,4P,D,SD,5MM,10RDL,92CM; OCTA,STD,48P,2-2-2-2-2,F-CURVE; SMARTABLATE IRR TUBE SET
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female