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

Catalog Number	D134703
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	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) and the catheter would not flush mid-case and was occluded.They high-power flushed the catheter with no resolution.When the catheter was replaced, the issue was resolved.Replacement catheter requested.No adverse patient consequence was reported.Additional information was received.It was indicated that there was no error noted on the ngen irrigation pump.Ablation would not initiate.A catheter temperature too high error was displayed on the ngen monitor (cut-off was not exceeded).This prevented the system from coming on ablation and led them to checking if irrigation was working, even though the pump displayed low flow of 2 ml and was running.Temperature settings were set properly on the monitor for ablation.The catheter was removed from the body to check irrigation flow.They checked the catheter tip for occlusion in the irrigation holes of the catheter and did not find anything.They tried to high flow flush and there was no response of fluid through the catheter, just pressure buildup in the tubing at the back end.When they replaced the stsf catheter, the irrigation worked properly after that.
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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) and the catheter would not flush mid-case and was occluded.They high-power flushed the catheter with no resolution.When the catheter was replaced, the issue was resolved.Replacement catheter requested.No adverse patient consequence was reported.Additional information was received.It was indicated that there was no error noted on the ngen irrigation pump.Ablation would not initiate.A catheter temperature too high error was displayed on the ngen monitor (cut-off was not exceeded).This prevented the system from coming on ablation and led them to checking if irrigation was working, even though the pump displayed low flow of 2 ml and was running.Temperature settings were set properly on the monitor for ablation.The catheter was removed from the body to check irrigation flow.They checked the catheter tip for occlusion in the irrigation holes of the catheter and did not find anything.They tried to high flow flush and there was no response of fluid through the catheter, just pressure buildup in the tubing at the back end.When they replaced the stsf catheter, the irrigation worked properly after that.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The temperature, impedance, and irrigation tests were performed, and the device was found working correctly.No temperature, impedance or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 31220851l number, and no internal actions related to the reported complaint condition were identified.The 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 catheter instructions for use contain the following recommendations: when rf energy 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.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.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: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION 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: 19449980
• Report Number: 2029046-2024-01791
• Device Sequence Number: 12896581
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Catalogue Number: D134703
• Device Lot Number: 31220851L
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: CARTO 3 SYSTEM.; THMCL SMTCH SF UNID, TC, J.; UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown