MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	DI7TCFLRT
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	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a celsius¿ thermo-cool¿ electrophysiology catheter and an irrigation issue during use on patient occurred.The catheter has an irrigation defect at the tip which causes an increase in temperature during ablation.The procedure was not delayed due to the reported event.The procedure was successfully completed.No patient consequence.Additional information was received.The suspected device for the reported flow/irrigation issue was the catheter.The ngen pump was used.The high temperature error was noted from the irrigation pump.They replaced the catheter to resolve the irrigation issue.Correct catheter settings were selected on the ngen generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.The temperature cut-off value was exceeded by a few seconds.They do not need servicing on the equipment.They are using the ngen pump and ngen generator without problems now.The high temperature error was assessed as not 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 during use on the patient was assessed as mdr reportable.
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31084927m and no internal actions related to the complaint was found during the review.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a celsius¿ thermo-cool¿ electrophysiology catheter.The catheter has an irrigation defect at the tip which causes an increase in temperature during ablation.The procedure was not delayed due to the reported event.The procedure was successfully completed.No patient consequence.Additional information was received.The high temperature error was noted from the irrigation pump.They replaced the catheter to resolve the irrigation issue.The bwi product analysis lab received the device for evaluation on 13-may-2024.The device evaluation was completed on 15-may-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, temperature and impedance, and irrigation tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.Temperature and impedance test 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 batch number, and no internal actions 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 usage of the device that compromised its performance.The instructions for use contain the following recommendations: when rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum if present.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: CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY 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: 19085549
• Report Number: 2029046-2024-01185
• Device Sequence Number: 7819793
• Product Code: OAD
• UDI-Device Identifier: 10846835000450
• UDI-Public: 10846835000450
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/08/2024

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: 06/28/2026
• Device Catalogue Number: DI7TCFLRT
• Device Lot Number: 31084927M
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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: NGEN RF GENERATOR; UNK_NGEN PUMP
• Patient Sex: Unknown