MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BNI75TCDFH
Medical Device Problem Codes	Insufficient Cooling (1130); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).
Event or Problem Description
It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with an ez steer¿ thermocool® nav bi-directional catheter and an irrigation issue occurred.An error was detected on the smartablate due to a temperature increase, causing the application to crash.The patient's ez steer¿ thermocool® nav bi-directional catheter was removed and the irrigation was increased to 70.They found that it was clogged and was not irrigating properly.Surgery delayed 5 minutes.The procedure was completed successfully with no patient consequence.Additional information was received.This issue was noted during the device was used on the patient.The issue was discovered on the smartablate due to temperature increase, causing the application to crash.The patient's ez steer¿ thermocool® nav bi-directional catheter was removed and the irrigation was increased to 70.The correct catheter settings were selected on the generator.The pump was not switching from ¿low¿ to ¿high¿ flow during ablation.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The temperature increase causing the application to crash issue was assessed as non mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The irrigation issue was assessed as mdr reportable.
Additional Manufacturer Narrative
Additional information was received on 27-dec-2023.The ablation stopped because of high temperature.The irrigation was partially blocked during the occlusion.Clarification was requested on initially reported under the 3500a inital, ¿the pump was not switching from ¿low¿ to ¿high¿ flow during ablation.¿ response was this was not applicable (n/a).The bwi product analysis lab received the device for evaluation on 03-jan-2024.The device evaluation was completed on 08-jan-2024.It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with an ez steer¿ thermocool® nav bi-directional catheter.An error was detected on the smartablate due to a temperature increase, causing the application to crash.The patient's ez steer¿ thermocool® nav bi-directional catheter was removed and the irrigation was increased to 70.They found that it was clogged and was not irrigating properly.The procedure was completed successfully with no patient consequence.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and temperature, impedance, pump flow, and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.Afterward, a pump flow and pressure gage test was performed and no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues 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.As part of biosense webster¿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 reference number: (b)(4).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18314047
• Report Number: 2029046-2023-02921
• Device Sequence Number: 6718127
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 01/23/2024

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 Expiration Date: 07/26/2026
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 31104964M
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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: UNK PUMP; UNK_SMARTABLATE GENERATOR
• Patient Sex: Unknown