MAUDE Adverse Event Report: Biosense Webster Inc TRUPULSE¿ Generator; Percutaneous Cardiac Abl Cath for Treatmt of AFib w Irreversible Electroporation

Catalog Number	D141702
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a pulse field ablation (pfa) procedure for atrial fibrillation (afib) with a trupulse generator and the foot pedal became stuck and continued ablation.It was also reported that during the procedure, when the physician had released the ngen¿ foot pedal in order to come off pfa ablation, the trupulse¿ generator did not stop or cut off pfa ablation.The caller confirmed that there were no errors or alerts displayed on the trupulse¿ generator.The caller reported that they were able to come off pfa ablation by manually selecting "stop" on the trupulse¿ monitor instead.The caller reported that the physician did not feel comfortable continuing ablation with the same ngen¿ foot pedal.The ngen¿ foot pedal was replaced with one from another system, and the procedure was continued with no other issues.The caller confirmed that a trupulse¿ generator was in use for ablation at the time of the issue.Additional information received indicated that when pressed, the foot pedal did ablate but the foot pedal got stuck and continued ablating.Ablation was stopped by pressing the button on the monitor.There were no error codes or alarms.
Additional Manufacturer Narrative
The hardware investigation has begun but it has not been 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 ref.#(b)(4).

• Brand Name: TRUPULSE¿ Generator
• Common Device Name: Percutaneous Cardiac Abl Cath for Treatmt of AFib w Irreversible Electroporation
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Sanmina Israel LTD.; haroshet street no. 5; shlomo shrira st; ma'alot-tarshiha IL
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50725666
• Report Number: 3013300026-2026-02981
• Device Sequence Number: 13416862
• Product Code: QZI
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(11)241201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P240006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial

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 Catalogue Number: D141702
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown