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	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smartablate irrigation tubing set.An unknown foreign object was within the sterile packaging of the smartablate irrigation tubing set.When they opened the irrigation tubing, a small, blue, latex plastic piece was seen in the package.The staff discarded the plastic piece and the tubing.They opened a new set of irrigation tubing and the issue was resolved.The procedure continued.No patient consequence was reported.Additional information was received.The issue was noted before use.The foreign material was described as a blue, latex, flimsy material about 1-2cm large.Material was loose in packaging.It was confirmed that the product was discarded, not used.
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Picture was 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).
Additional Manufacturer Narrative
During an internal review on 19-dec-2025, noted a correction to the 3500a initial under the h 4.Device manufacture date field as processed as 29-jul-2025.Should have been processed as 02-jul-2025.Therefore, updated.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smartablate irrigation tubing set.An unknown foreign object was within the sterile packaging of the smartablate irrigation tubing set.When they opened the irrigation tubing, a small, blue, latex plastic piece was seen in the package.The staff discarded the plastic piece and the tubing.Additional information was received.The issue was noted before use.The foreign material was described as a blue, latex, flimsy material about 1-2cm large.Material was loose in packaging.The picture investigation details.A picture was received for evaluation following johnson & johnson medtech's procedures.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation findings code of ¿appropriate investigation findings term/code not available (c22)¿ represents photo analysis.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): HARMAC MEDICAL PRODUCTS; maquiladoras no. 320-a; colonia ciudad industrial; tijuana
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23846816
• Report Number: 2029046-2025-04231
• Device Sequence Number: 10030357
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: (01)10846835009743(17)260530(10)3015168
• 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
• Report Date (Section B): 01/15/2026

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: 05/30/2026
• Device Catalogue Number: SAT001
• Device Lot Number: 3015168
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: NGEN SYSTEM
• Patient Sex: Unknown