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	03/11/2026
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 a patient underwent an atrial fibrillation (afib) procedure with smart ablate irrigation tube set.When attempting to flush the smart ablate irrigation tube set from the ngen¿ monitor, it was noticed that there was no high or low flow option displayed.The smartablate irrigation tube set was flushed without resolution.The smartablate irrigation tube set was replaced and the issue was resolved.The procedure continued with no further issues.There was no patient consequence reported.Attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Additional information was received on 31-mar-2026 which indicated the product was discarded and not available for return.Since the device has been reported as discarded, no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.H4.Device manufacture date has been added on 09-apr-2026.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 investigation was completed on 04-may-2026.An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record review was performed for the finished device (b)(6) number, and no internal actions to the complaint were found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.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: 24818666
• Report Number: 2029046-2026-01153
• Device Sequence Number: 21231159
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: (01)10846835009743(17)260630(10)AC10036395
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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: 06/30/2026
• Device Catalogue Number: SAT001
• Device Lot Number: AC10036395
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 05/04/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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
• Patient Sex: Unknown