MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D131802
Medical Device Problem Codes	Complete Blockage (1094); Coagulation in Device or Device Ingredient (1096); Insufficient Cooling (1130); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
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.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 a cardiac ablation procedure with a thermocool® sf nav uni-directional catheter and blood clots/thrombus were discovered.During an atrial flutter ablation, catheter was properly flushed prior to insertion with flow running at 2ml/min as per the automated settings.Upon ablation, temperature was rising and rf stopped.Decision to remove catheter and check irrigation.Irrigation was blocked.Catheter replaced.Patient seemed to be clotting, few clots observed inside the sheaths.The surgery was not delayed and completed successfully.There was no patient consequence.The thrombus was found while rinsing the sheath when exchanging catheters.There were no error messages or product problems.Issues related to temperature were encountered as the flow was blocked within the catheter while delivering the rf.The temperature was rising and the rf was stopped due to high temperature.The ngen generator was set to power control, 35watts.Temp noted around 40 dégrees.Impedance 110, 35 watts and below due to high temperature.No activated clotting time (act), procedure was right sided.The physician considered the amount of thrombus/clot to be excessive but not related to device or its utilization and not a risk to the patient.The patient has not exhibited any neurological symptoms since the procedure.A ngen pump was also used in this case.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a thermocool® sf nav uni-directional catheter and blood clots/thrombus were discovered.During an atrial flutter ablation, catheter was properly flushed prior to insertion with flow running at 2ml/min as per the automated settings.Upon ablation, temperature was rising and rf stopped.Decision to remove catheter and check irrigation.Irrigation was blocked.Catheter replaced.Patient seemed to be clotting, few clots observed inside the sheaths.The surgery was not delayed and completed successfully.There was no patient consequence.On 21-aug-2023, additional information was received confirming that during this procedure, no bwi sheath was used.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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 30826509l and no internal actions 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.Note: h6.Medical device problem code has been corrected from device contamination with body fluid (a180103) to coagulation in device or device ingredient (a030202).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: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17406270
• Report Number: 2029046-2023-01613
• Device Sequence Number: 5962199
• Product Code: LPB
• UDI-Device Identifier: 10846835009262
• UDI-Public: 10846835009262
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030031/S034
• 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): 09/11/2023

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: 07/24/2025
• Device Catalogue Number: D131802
• Device Lot Number: 30826509L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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 PUMP, EU CONFIGURATION.; NGEN RF GENERATOR.; UNKNOWN SHEATH.
• Patient Sex: Unknown