MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCBH
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned for evaluation.Visual inspection and electrical test of the returned device were performed following johnson & johnson medtech procedures.Visual analysis of the returned sample revealed that the peek housing was broken leaving internal parts exposed.An electrical test was performed, and no electrical issues were found; however, error 105 was displayed on the screen due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device and no internal actions related to the complaint were found during the review.The noise issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.The potential cause of the damage to the peek housing cannot be determined; however, it could be related to the handling during the return to be analyzed and the cause of the magnetic error displayed but it cannot be conclusively determined.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a navistar thermocool for which biosense webster¿s product analysis lab (pal) identified the peek housing was broken leaving internal parts exposed.It was initially reported by the customer that during the operation, the signal interference (noise) was observed on intracardiac (ic) channels on both the carto3 system and the recording system.The physician did have other intact ecg signals available to monitor patient heart rhythm.A second device was used to complete the operation.There was no adverse event reported on patient.The customer's reported noise on ic signals is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 18-feb-2026, the bwi pal revealed that a visual inspection of the returned device found the peek housing was broken leaving internal parts exposed.These findings were reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

• Brand Name: NAVISTAR THERMOCOOL
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24574434
• Report Number: 2029046-2026-00791
• Device Sequence Number: 13069778
• Product Code: OAD
• UDI-Device Identifier: 10846835008333
• UDI-Public: (01)10846835008333(17)280319(10)31596779M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: NI75TCBH
• Device Lot Number: 31596779M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown