MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TRUPULSE GENERATOR, US; PERCUTANEOUS CARDIAC ABL CATHETER FOR TREATMENT OF AFIB WITH IRREVERSIBLE ELECTR

Catalog Number	D141702
Medical Device Problem Codes	Failure to Power Up (1476); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a trupulse generator, us and it was not powering on.The monitor and remote had power.But there were no lights or noises coming from the console.Different outlets were tried, the power cable was reseated, and they exchanged the power cable--all without resolution.The console was replaced and the procedure continued.However, a field service engineer went onsite and found an error 4 on two different monitors/stands.The console was replaced and booted up without errors.But after 5 minutes the console shut off and started smoking out of the sides.The power was disconnected.The engineer tested outlets with a voltmeter after waiting for the smoke to clear the room.
Additional Manufacturer Narrative
The hardware investigation has begun but it has not been completed at this time.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
On 30-oct-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a trupulse generator, us and it was not powering on.The monitor and remote had power.But there were no lights or noises coming from the console.Different outlets were tried, the power cable was reseated, and they exchanged the power cable--all without resolution.The console was replaced and the procedure continued.Device evaluation details: the manufacturer performed evaluation on the device.Also, technical services performed an evaluation at the device location site.Work order service report was sent to johnson & johnson medtech for evaluation.Evaluation was performed on the device's console.It was deemed that the console had a defective component (ea-3002-060f) and the power supply unit was not working.After these components were replaced, the initialization issue was resolved.In a further date, the generator was also evaluated and the error 4 and the smoke coming from the console were confirmed.The field service engineer initially replaced the fuses that were initially suspected as the main problem.Since this replacement did not solve the error, the system was declared doa (dead on arrival) and put out of service.Manufacturer evaluated the system again, but the issue was no longer reproduced after their evaluation.A device history record evaluation was performed for the finished device number (b)(6), and no internal actions related to the reported condition were identified.Internal actions are being followed to further investigate error 4 in trupulse generators.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: TRUPULSE GENERATOR, US
• Common Device Name: PERCUTANEOUS CARDIAC ABL CATHETER FOR TREATMENT OF AFIB WITH IRREVERSIBLE ELECTR
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22546793
• Report Number: 2029046-2025-02383
• Device Sequence Number: 8468276
• Product Code: QZI
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(17)250414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P240006
• 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): 11/13/2025

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 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: 06/23/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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