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

Catalog Number	SAT001
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).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 lot number ac9357738 and no internal action related to the complaint was found during the review.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 premature ventricular contraction cardiac ablation procedure with a qdot micro catheter and a smartablate irrigation tubing set.Just before ablation, the qdot micro catheter and the smartablate irrigation tubing set could not perform flushing.Reconnected and performed flushing, but could not.The catheter was replaced with an ablation catheter from another company.The procedure was continued and completed without patient consequence.This irrigation issue was assessed as mdr reportable under both the qdot micro catheter and the smartablate irrigation tubing set.
Additional Manufacturer Narrative
Additional information was received on 18-nov-2025.The tubing was not replaced.The ngen pump was the cause of the irrigation issue.The ngen pump system was switched to the non-bw system (non- irrigating system).Therefore, the pump was not replaced and was not used.Due to the additional information provided stating that the tubing was not replaced and that the ngen pump was the cause of the irrigation issue, downgraded the smartablate irrigation tubing set to not mdr reportable.Therefore, updated h6.Medical device problem code from "obstruction of flow (a1409)" to "adverse event without identified device or use problem (a24)".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: 22353031
• Report Number: 2029046-2025-02123
• Device Sequence Number: 7925268
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: (01)10846835009743(17)250930(10)AC9357738
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 09/30/2025
• Device Catalogue Number: SAT001
• Device Lot Number: AC9357738
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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: JPN CARTO 3 SYSTEM.; NGEN PUMP, JAPAN CONFIGURATION.; QDOT MICRO, BI, TC, D-F.; UNK CABLE.
• Patient Sex: Unknown