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 Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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 that indicated elevated impedence readings.The medical team was unable to complete a tpi (tissue proximity indication) calibration as the impedance readings were ranging in the 260 ohm range.However, no errors were displayed for the impedence values or any other issue on the trupulse generator or carto 3 system.The stop button was functioning.The reprocessed generator cable was replaced with a new out of the box cable without resolution.The catheter was also replaced without resolution.The catheter and cable were exchanged a second time and the issue persisted.Next, the cable from the generator to the patient interface unit (piu) had been replaced.The generator had then been rebooted.Meanwhile, the physician continued to ablate with a third varipulse catheter.When the catheter was advanced to the rspv (right superior pulmonary vein), the impedance values elevated above range and all values were red.The procedure was completed.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: technical services performed remote evaluation of the device.Work order service report was sent to johnson & johnson medtech for analysis.No failure was found during the evaluation.Other circumstances may have affected device performance.System is fully operational.Device history record evaluation is not required, as the failure mode observed is not related to the manufacturing process.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).
Additional Manufacturer Narrative
On 5-jan-2026, the product investigation was updated with a device history record.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 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: 23898282
• Report Number: 2029046-2025-04299
• Device Sequence Number: 5029618
• Product Code: QZI
• UDI-Device Identifier: 10846835025248
• UDI-Public: (01)10846835025248(11)240922
• 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): 01/26/2026

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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; VARIPULSE CATHETER (3 OF THEM)
• Patient Sex: Unknown