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

Catalog Number	SAT001
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).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 fibrillation (afib) ablation and during the procedure, the irrigation solution was not dropping to the irrigation tubing.They changed the irrigation bag and the tubing, and the issue was resolved.No adverse patient consequence was reported.
Additional Manufacturer Narrative
Additional information was received on 17-jun-2025.The type of pump used was provided.Therefore, the concomitant product section was updated.There was no error on the pump.However, the generator did not allow ablation because of the temperature error.The correct catheter settings were selected on the generator.There were no issues with flow rate change at the start of ablation.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
The biosense webster, inc.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
Device investigation was completed on 20-aug-2025.It was reported that a patient underwent an atrial fibrillation (afib) ablation and during the procedure, the irrigation solution was not dropping to the irrigation tubing.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.Tubing was irrigating correctly, no occlusion or issues were observed.A device history record evaluation was performed for the finished device number lot ac9311970 and no internal action related to the complaint was found during the review.The irrigation 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: inspect the sterile packaging and tubing set prior to use.Do not use if opened or damaged.Do not reuse, reprocess or resterilize.Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure.Verify that the tubing set is free of leaks or defects.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: 22181562
• Report Number: 2029046-2025-01889
• Device Sequence Number: 8356080
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: (01)10846835009743(17)250831(10)AC9311970
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: SAT001
• Device Lot Number: AC9311970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 08/14/2025; 08/20/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/15/2025; 08/19/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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: SMA PUMP STOCKERT.; SMARTABLATE GENERATOR KIT-WW.; SMARTABLATE GENERATOR KIT-WW.; THMCL SMTCH SF BID, TC, D-F.; THMCL SMTCH SF BID, TC, D-F.; UNKNOWN CABLE.; UNKNOWN CABLE.; UNKNOWN SALINE BAG.; UNKNOWN SALINE BAG.
• Patient Sex: Unknown