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

Catalog Number	D134801
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a cardiac ablation procedure with a thermocool smarttouch sf catheter and the patient experienced a cardiac tamponade which required drainage.The report indicated that pre-op, a thermocool smarttouch sf catheter had error 105 occurred during connecting the catheter and cable.The issue was not resolved by replacing the cable.The issue was resolved by replacing the thermocool smarttouch sf catheter with another new one (thermocool smarttouch sf catheter / lot #: 31528832l).During the procedure, a cardiac tamponade occurred, and drainage was performed.The vital signs stabilized.Puncture was performed with a rf needle.No extended hospitalization.After the soundstar eco catheter was being inserted into the patient's body, the echo screen display disappeared midway and it was not recognized.A newly opened catheter (lot #: g947359) was also not recognized.The timing was while confirming the pericardial effusion.Additionally, the issue was resolved by replacing with another soundstar eco catheter (the second one).Cf monitoring methods were dashboard, vector, and visitag.Visitag coloring settings was tag index.Visitag additional filters was impedance drop.Additional information was received on 11-jun-2025.The patient did not require cardiac surgery.Outcome of the adverse event mentioned improved, one catheter was used for each.No evidence of steam pop.No error messages were observed on biosense webster equipment during the procedure.Additional information received on 15-jun-2025, the adverse event was discovered post use of bwi products.After the procedure, the blood pressure decreased to the 70mmhg level, and the echocardiogram revealed that pericardial effusion had increased compared to intraoperatively.The physician¿s opinion on the cause of this adverse event was the patient¿s condition.The event occurred probably transseptal phase.Outcome of the adverse event fully recovered (no residual effects).Prior to noting the cardiac tamponade, ablation was performed.The procedural act was over 300 seconds.Two transseptal puncture sites were performed during the procedure.No relevant tests/laboratory data or other relevant history/preexisting condition noted.The flow setting used were under 30w: 8ml/min, above 31w: 15ml/min, pre: 2sec, and post: 4sec.Correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.The adverse event was assessed as mdr reportable under the thermocool smarttouch sf catheter / lot #: 31528832l.The recognition issue and the 105 error issue were assessed as non mdr reportable.The user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.
Additional Manufacturer Narrative
The investigation was completed on 26-sep-2025.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 31528832l 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.If the product is received at a later date, the investigation will be updated as applicable.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 22392341
• Report Number: 2029046-2025-02176
• Device Sequence Number: 18409544
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)280108(10)31528832L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/08/2025

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: D134801
• Device Lot Number: 31528832L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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: RF NEEDLE.; SMARTABLATE GEN. KIT (JAPAN).; SMARTABLATE PUMP KIT (JAPAN).; SOUNDSTAR ECO GE 8F CATHETER.; SOUNDSTAR ECO GE 8F CATHETER.; THMCL SMTCH SF BID, TC, D-D.; UNK CABLE.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian