MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ THERMOCOOL¿ UNI-DIRECTIONAL CATHETERHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	DI7TCFLRT
Medical Device Problem Codes	Insufficient Cooling (1130); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31351334m and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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 atrial flutter ablation procedure with a celsius¿ thermocool¿ uni-directional catheter and the patient experienced cardiac perforation that required prolonged hospitalization.This was for treatment of atrial flutter in the right atrium.Celsius¿ thermocool¿ uni-directional catheter was used in combination with a smartablate generator.The ablation was performed at 50watt.This was an ablation procedure using the fluoroscopy system only, without the use of the carto system for mapping.It was reported that during the procedure, the temperature indicator light of the generator flashed several times, indicating that the temperature at the tip of the catheter rose above 43ºc and once during the procedure, the temperature indicator light lit continuously, and the generator's protective mechanism was activated, cutting off the operation of the generator when the temperature rose above 50ºc.After the generator cutoff and after the electrophysiologist indicated that he did not feel he was pressing too hard on the tissue, the medical team decided to increase the irrigation to 45ml/min.Despite the increased irrigation, the temperature indicator light continued to occasionally flash (not continuously) as an indication of temperature increases.It should be noted that according to report, there were also two instances of steam pop during the procedure.The electrophysiologist reported that he treated the atrial flutter, the patient returned to sinus rhythm and the procedure ended.Upon removing the catheter, the electrophysiologist checked and did not notice any char.Generator ablation mode and thresholds: ablation settings: power: 50w, temperature settings: warning 43 , cut-off 50.Impedance setting: max cut-off 250 ; min cut-off: 50.Flow: 17/30 ml/min - raised to 45 ml/min.During steam pop, the noted temperature was around 48 degrees, impedance was 100, and power was 50 w.The length of ablation was 5 seconds approximately the first time and after a minute approximately the second time.At the end of the procedure, the medical team noticed that the patient's blood pressure was low, and thus an echocardiogram was performed to check if there was an accumulation of fluid in the pericardium.Since no fluid accumulation was observed, it was decided to transfer the patient to his room for monitoring.After about an hour, a follow-up echocardiogram was performed, and the doctor noted that in his opinion, there was fluid in the pericardium, and it was decided to continue monitoring in order to consider whether a puncture for fluid aspiration was necessary.According to the electrophysiologist's report, the patient stabilized and recuperated without the puncture for fluid aspiration.Patient was still in pain but improving.His blood pressure returned to normal.He was under observation and monitoring, and echocardiograms were being performed regularly.On 19-jan-2025, additional information was received indicating there was a perforation located in the cti line (cavotricuspid isthmus).The patient did require extended hospitalization of 2 more days in order to observe the blood pressure turn to normal.The physician's opinion on the cause of the adverse event was that he is not sure because the catheter was thrown away by the hospital staff but he thinks it might be the catheter due to the alert that appeared during the procedure.No transseptal puncture was done.There were no issues with flow rate change at the start of ablation.The only error message observed was the power control alert.Based on the new information received on 19-jan-2025, the event was reassessed as an mdr reportable event.

• Brand Name: CELSIUS¿ THERMOCOOL¿ UNI-DIRECTIONAL CATHETERHETER
• 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: 21345124
• Report Number: 2029046-2025-00378
• Device Sequence Number: 7958377
• Product Code: OAD
• UDI-Device Identifier: 10846835000450
• UDI-Public: (01)10846835000450(17)240603(10)31351334M
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DI7TCFLRT
• Device Lot Number: 31351334M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: SMARTABLATE GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White