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

Catalog Number	D133602
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	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with thermocool smarttouch catheter and an irrigation issue occurred with the device used in the patient.After 6 ablation points, continuous bubble alarm.The tubing was changed and flushed again but still bubbles after a couple of seconds of ablation.The ablation catheter was extracted out of the patient and the flush was inspected.Only one hole open of the 6 holes.Catheter was changed with a new one and problem was solved.The procedure was delayed by 10 minutes due to the reported issue.The procedure was successfully completed.No patient consequence.Additional information was received.The issue was not noted before the device was used on the patient.Bubble error on the smart ablate generator.Steps taken to resolve the irrigation issue was to flush the tubing out of the patient until bubble error disappears (t lock).The bubble alarm was assessed as non mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event was low.The irrigation issue with the device used in the patient was assessed as mdr reportable.
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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with thermocool smarttouch catheter.After 6 ablation points, continuous bubble alarm.The tubing was changed and flushed again but still bubbles after a couple of seconds of ablation.The ablation catheter was extracted out of the patient and the flush was inspected.Only one hole open of the 6 holes.Catheter was changed with a new one and problem was solved.The procedure was delayed by 10 minutes due to the reported issue.The procedure was successfully completed.No patient consequence.The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 17-jul-2025.A visual inspection and irrigation tests of the returned device were performed in accordance with j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.Irrigation tests were performed, and the device was irrigating correctly.No irrigation issues were observed.Additionally, no obstructed irrigation holes nor bubble alarms were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation and bubble alarm issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of the 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).
Additional Manufacturer Narrative
Initially reported in the 3500a initial under b3.Date of event ¿20-apr-2025¿.Additional information was received on 17-aug-2025, updating this date to ¿20-may-2025¿.Therefore, updated b3.Date of event field.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
• 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: 22190811
• Report Number: 2029046-2025-01915
• Device Sequence Number: 13196463
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)280305(10)31582079M
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup,Followup
• Report Date (Section B): 08/18/2025

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: D133602
• Device Lot Number: 31582079M
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/17/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/13/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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 KIT-US.; UNK_SMARTABLATE PUMP TUBING.; UNK_SMARTABLATE PUMP.
• Patient Age: 28 YR
• Patient Sex: Male