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	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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 and when the physician stepped on the trupulse foot pedal, ablation came on but when he released the foot pedal, ablation did not come off, it continued.This occurred near the end of the procedure; therefore, the foot pedal was not replaced.A couple more lesions were done using the primary monitor to stop ablation.There was no error message.The foot pedal was tested in the trupulse connectivity tab and there were no issues.In addition, the foot pedal was tested post case and the issue could not be replicated.There was no patient consequences reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a trupulse¿ generator and when the physician stepped on the trupulse foot pedal, ablation came on but when he released the foot pedal, ablation did not come off, it continued.This occurred near the end of the procedure; therefore, the foot pedal was not replaced.A couple more lesions were done using the primary monitor to stop ablation.There was no error message.The foot pedal was tested in the trupulse connectivity tab and there were no issues.In addition, the foot pedal was tested post case and the issue could not be replicated.There was no patient consequences reported.Hardware evaluation details: technical services performed a remote evaluation of the device.The work order service report was sent to johnson & johnson medtech for evaluation.No failure was found during the evaluation.Other circumstances may have affected device performance.The system is fully operational.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of johnson & johnson medtech's quality process.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
• 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.; 5 haroshet st; ma¿alot plant; ma'alot-tarshiha 21018 02; IS 2101802
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21080890
• Report Number: 2029046-2025-00044
• Device Sequence Number: 18267162
• Product Code: QZI
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(11)240922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/02/2025

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: 12/10/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2024
• 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