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

Catalog Number	BDI75TCDFRT
Medical Device Problem Codes	Insufficient Cooling (1130); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 supraventricular tachycardia ablation procedure with an ez steer thermocool and 3 irrigation holes were not irrigating.It was reported that the nonnav catheter kept having temperature rises on ngen generator remote monitor.The caller stated they were not present during the procedure.The caller stated the catheter was removed from the body to flush.The caller stated they noticed 3 irrigation holes were not irrigating.The correct catheter setting were selected on the generator and there were no flow rate the caller stated the catheter was replaced, the issue resolved.The procedure was continued.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia ablation procedure with an ez steer thermocool and 3 irrigation holes were not irrigating.It was reported that the nonnav catheter kept having temperature rises on ngen generator remote monitor.The caller stated they were not present during the procedure.The caller stated the catheter was removed from the body to flush.The caller stated they noticed 3 irrigation holes were not irrigating.The correct catheter settings were selected on the generator and there were no flow rate the caller stated the catheter was replaced, the issue resolved.The procedure was continued.There was no patient consequence.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 7-jul-2025.Following j&j medtech procedures, a visual inspection, irrigation and temperature and impedance test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to the generator and an ablation cycle was performed and the device was found working correctly.No temperature or impedance issues were observed.An irrigation test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The high temperature and irrigation issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.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).

• Brand Name: EZ STEER 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: 22391659
• Report Number: 2029046-2025-02170
• Device Sequence Number: 21122125
• Product Code: OAD
• UDI-Device Identifier: 10846835002874
• UDI-Public: (01)10846835002874(17)280421(10)31629191M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: BDI75TCDFRT
• Device Lot Number: 31629191M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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: NGEN RF GENERATOR, US; NONNAV CATHETER
• Patient Sex: Unknown