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 Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a trupulse generator, us and the physician had released the pedal after the first delivery and the generator still appeared as it was loading for the next ablation.And then the next delivery still went through all by itself.The third delivery was stopped by using the console.The pedal was checked and was found working just fine, and the medical team suspected a generator issue and requested for a field service engineer to inspect the device.
Additional Manufacturer Narrative
On 30-sep-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a trupulse generator, us and the physician had released the pedal after the first delivery and the generator still appeared as it was loading for the next ablation.And then the next delivery still went through all by itself.Device evaluation details: technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for analysis.This system was reported to have a similar failure on a previous work order.Per the failure observed during the evaluation, the system was declared doa (dead on arrival) and put out of service.No further evaluation on the replaced system was performed at this time.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.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: 22722607
• Report Number: 2029046-2025-02575
• Device Sequence Number: 9627738
• Product Code: QZI
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(11)241104
• 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): 10/22/2025

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: 07/10/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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