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

Catalog Number	D134702
Medical Device Problem Codes	Device Alarm System (1012); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
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 during an atypical flutter procedure, after starting ablation with the catheter the medical team got the bubble alarm from the smartablate generator.When flushing, the team noticed that there was blood flowing back into the tubing up until the pump sensor.The tubing was checked and confirmed to be positioned correctly.Flushing was attempted by opening the 3-way tab to air, and after reconnection the catheter was flushed but no flow was seen.The tubing was then disconnected from the catheter, and a syringe flush was attempted instead but there was extreme resistance.The device had already been used inside of the patient prior to noting the irrigation issue.The correct catheter settings were selected on the generator.There were no flow rate change issues at the start of ablation.The catheter was replaced (and the same tubing was used) and the issue resolved.After an approximately troubleshooting period of 5 minutes, the procedure continued.The case was completed without patient consequences.
Additional Manufacturer Narrative
On 9-feb-2026, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 25-mar-2026, the product investigation was completed.It was reported that during an atypical flutter procedure, after starting ablation with the catheter the medical team got the bubble alarm from the smartablate generator.When flushing, the team noticed that there was blood flowing back into the tubing up until the pump sensor.The tubing was checked and confirmed to be positioned correctly.Flushing was attempted by opening the 3-way tab to air, and after reconnection the catheter was flushed but no flow was seen.The tubing was then disconnected from the catheter, and a syringe flush was attempted instead but there was extreme resistance.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and irrigation tests of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.An irrigation test was performed and pressure values out of specifications were observed.Dissection was performed around the shaft area and the irrigation tube was found blocked with reddish material.A manufacturing record evaluation was performed for the finished device (b)(6), and no internal action was found during the review.The irrigation and bubble issues reported by the customer were confirmed as the blockage of the irrigation tube could be related.The potential cause of the irrigation tube blocked could not be conclusively determined.The instructions for use contain the following recommendations: purge the catheter and irrigation tubing with heparinized normal saline prior to insertion of the catheter inside the patient body.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.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 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: 24248676
• Report Number: 2029046-2026-00365
• Device Sequence Number: 9593039
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: (01)10846835009781(17)280909(10)31748754L
• 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,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31748754L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/25/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/03/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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: SMARTABLATE GENERATOR.; TUBING.
• Patient Sex: Unknown