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

Catalog Number	SAT001
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not returned for analysis; however, pictures were provided by the customer.Evaluation is still in progress.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.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 smartablate and the tube appeared cloudy.After opening, the inside of the tube appeared cloudy, and when pressed with a finger, it seemed to peel off.Considering the risk of foreign material entering the patient's body, a new tubing set with the same lot number was taken out, and a similar appearance was confirmed.When the third tubing set with a different lot number was used, it was transparent and did not have any issues.So, the third tubing set was used.The procedure was completed without adverse patient consequence.
Additional Manufacturer Narrative
H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.It was reported that a patient underwent a cardiac ablation procedure with a smartablate and the tube appeared cloudy.Device investigation details: a picture was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the picture provided by the customer, cloudiness condition and microbubbles condition were observed inside the smartablate irrigation tubing.No other damage or anomalies were observed.The customer complaint was confirmed based on the picture received.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and irrigation test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.An irrigation test was performed, and no issues were observed.No cloudiness or bubbles were observed.A device history record evaluation was performed for the finished device lot number, and no internal action was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The foreign material inside the tubing issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The instructions for use contain the following information: verify that the smartablate¿ irrigation tubing set is free of leaks or defects and that all bubbles have been flushed from the tube set.If bubbles are present, continue flushing until they are passed through the tubing set.In addition, bubbles with no movement and cloudiness on the smart ablate tubing have been investigated by a cross functional team and the engineering analysis suggests that a plasticizer migration in the tubing product may have contributed to a change in tubing appearance including opacity, increase in lumen roughness as well as microbubble adhesion.Plasticizer migration is a known phenomenon in softer polyvinyl chloride (pvc) materials like our tubing set.Additionally, an independent evaluation determined that the plasticizer is not toxic and will not result in adverse health effects in cardiac ablation patients under normal use conditions.Despite any change in tubing appearance, bubbles in the saline remain readily detectable.In addition, the bubble sensor on the smartablate pump uses ultrasound signals and the sensitivity of this sensor is unaffected by any change in tubing appearance.Customers should continue to properly prime and flush tubing per the instructions for use (ifu) and the smartablate irrigation tubing set preparation workflow.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: SMARTABLATE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; calle hertz 1525; parq indust antonio j bermudez; ciudad juarez 32470 ; MX 32470
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23987086
• Report Number: 2029046-2026-00038
• Device Sequence Number: 19978186
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: (01)10846835009743(17)260430(10)AC9835120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990017/S17
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: SAT001
• Device Lot Number: AC9835120
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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 IRR TUBE SET.
• Patient Sex: Unknown