MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF NON-NAV, D-F, TC; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BDI35DFRT
Medical Device Problem Codes	Obstruction of Flow (2423); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool sf and during the case, while using the catheter, impedance went above 200 and ablation stopped.They reconnected the cable, checked if the impedance patch was on the right position attached to the patient, and pulled out the catheter to check if there was any issue related to irrigation.They found out that irrigation hole was stuck and could not be flushed.When they changed the catheter, the issue was resolved.It was found out to be a catheter issue.No adverse patient consequence was reported.
Additional Manufacturer Narrative
During the case, while using the catheter, impedance went above 200 and ablation stopped.They reconnected the cable, checked if the impedance patch was on the right position attached to the patient, and pulled out the catheter to check if there was any issue related to irrigation.They found out that irrigation hole was stuck and could not be flushed.When they changed the catheter, the issue was resolved.It was found out to be a catheter issue.No adverse patient consequence was reported.Device investigation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, irrigation, temperature, and impedance test of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.The temperature and impedance test were performed, and the device was found working correctly.No impedance issues were observed.Finally, an irrigation test was performed, and the device was irrigated correctly.No irrigation issues were observed.No malfunctions were observed during the device analysis.A manufacturing record evaluation was performed for the finished device number lot 31250628l, and no internal actions related to the complaint were found during the review.The impedance 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 instruction for use (ifu) contains the following warnings and precautions: in the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip electrode inspected for coagulum before rf energy is reapplied.Protective impedance may reduce the risk of burns and permit continuous monitoring of the electrocardiogram during energy delivery.Apparent low power output, high impedance reading, or failure of the equipment to function correctly at normal settings may indicate faulty application of the indifferent electrode(s) or failure of an electrical lead.Do not increase power before checking for obvious defects or misapplication of the indifferent electrode or other electrical leads.In relation to the irrigation issue, the instructions for use contain the following warnings and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.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).

• Brand Name: THERMOCOOL SF NON-NAV, D-F, TC
• 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: 20860625
• Report Number: 2029046-2024-03909
• Device Sequence Number: 8865333
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: (01)10846835002812(17)270215(10)31250628L
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030031/S025
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: BDI35DFRT
• Device Lot Number: 31250628L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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
• Patient Sex: Unknown