MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TRUPULSE GENERATOR, US; PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION

Catalog Number	D141702
Medical Device Problem Codes	Unintended Power Up (1162); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a trupulse generator, us, and an error 202 ciu not connected occurred (meaning control interface unit).When the catheter was in the rspv (right superior pulmonary vein) the physician couldn't deliver pfa (pulse field ablation) with foot pedal.The j&j rep pressed stop button to clear the error, and while standing at the console the system started automatically delivering pfa.It happened to be in a spot that they wanted to deliver so the physician let the generator deliver a full round of pulses.They pressed stop button continuously and the physician disconnected the catheter.The 202 error was still present.The trupulse generator was rebooted and the error 202 cleared.However, the physician opted to continue the case with a ngen rf generator.The procedure was continued and completed.No patient consequences were reported.
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 22-dec-2026, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a trupulse generator, us, and an error 202 ciu not connected occurred (meaning control interface unit).Device investigation details: technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for analysis.The investigator confirmed log files have been uploaded to lightning and trupulse system has been used in several cases and issue was not present.System performing as intended.A device history record evaluation was performed for the (b)(6) finished device, and no internal actions related to the reported complaint condition were identified.As part of the quality process, the devices are manufactured, inspected, and released to approved specifications.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 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23823930
• Report Number: 2029046-2025-04176
• Device Sequence Number: 9974132
• Product Code: QZI
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(11)240714
• 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): 01/14/2026

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 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8.5 FR VARIPULSE CATHETER.; CATH TO GENERATOR CBL STERILE.; UNKNOWN RF CATHETER.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown