MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection, temperature and impedance test of the returned device were performed in accordance with j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.Temperature and impedance test were performed, and no issues were observed.No issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The char 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 instruction for use (ifu) contain the following recommendations: refer to the instructions for use for the rf generator for detailed operating instructions for rf ablation including information in choosing between temperature or power control modes.In the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip electrode cleaned of coagulum before rf energy is re-applied.Use only sterile saline and gauze pad to clean the tip; discontinue ablation immediately and replace the catheter if the tip temperature fails to rise during ablation.As part of johnson & johnson medtech¿s quality process, all 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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure with an ez steer nav for experienced concerning charring.It was initially reported by the customer that ablations were delivered with a 4 mm nav irrigated catheter and then the ngen system.We got good burns with settings: 60 seconds, 60 degrees celsius and 50w.We got good burns reaching power and then we started having lesions with just 1 w.We checked catheter tip and there was char.Char is a physical phenomenon of radiofrequency ablation and can be a normal result of the ablation process.The presence of char does not by itself represent a serious injury, nor is it necessarily the result of a device malfunction.As such, char is not mdr reportable.On 16-may-2025, additional information was received indicating temperature was at 60c and power was not greater than 10w.The correct catheter settings were selected on the generator.The physician did not consider the amount of char observed could cause a potential risk to this patient, however, did express concern over the charring.Based on physician¿s concern, the event was reassessed as an mdr reportable malfunction.

• Brand Name: EZ STEER NAV
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 22110677
• Report Number: 2029046-2025-01747
• Device Sequence Number: 20570512
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)280226(10)31582487M
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P990025/S12
• 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: BN7TCDF4L
• Device Lot Number: 31582487M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN GENERATOR.; UNKNOWN NGEN SYSTEM.
• Patient Sex: Unknown