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

Catalog Number D134805

Device Problems Insufficient Cooling (1130); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and an irrigation issue during use on the patient occurred.The thermocool® smart touch® sf bi-directional navigation catheter was not irrigating at all.When coming on ablation, there was a high temperature error displayed on the smartablate generator.The temperature cut-off was 40 degrees.The thermocool® smart touch® sf bi-directional navigation catheter was flushed and the line appeared to be "vibrating," but the fluid was not reaching the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The procedure continued.No patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The high temperature issue was assessed as non mdr reportable.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The irrigation issue during use on the patient was assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The thermocool® smart touch® sf bi-directional navigation catheter was not irrigating at all.When coming on ablation, there was a high temperature error displayed on the smartablate generator.The temperature cut-off was 40 degrees.The thermocool® smart touch® sf bi-directional navigation catheter was flushed and the line appeared to be "vibrating," but the fluid was not reaching the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The procedure continued.No patient consequence reported.The investigation was completed on 22-mar-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 dried blood residues at the dome area.The temperature and impedance test were performed, and the device was found working correctly.Then, an irrigation test was performed, and the device was not irrigating, and high-pressure values were observed due to the dried blood residues occluding the irrigation holes.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation issue reported by the customer was confirmed.Also, the temperature issue reported by the customer could be related to the irrigation issue observed.Therefore, customer complaint was confirmed.The potential cause of the dried blood residues on the dome cannot be determined.The instructions for use (ifu) contain the following guideline: do not use the temperature sensor to monitor tissue temperature or to guide power titration during ablation.The temperature sensor located within the tip section of the catheter does not reflect either electrode-tissue interface or tissue temperature due to the cooling effects of the saline irrigation of the electrode.The temperature displayed on the rf generator is the temperature of the cooled electrode, not tissue temperature.The temperature sensor is used to verify that the irrigation flow rate is adequate.Before initiating the application of rf energy, a decrease in electrode temperature confirms the onset of saline irrigation of the ablation electrode.Monitoring the temperature from the electrode during the application of rf energy ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 27-feb-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: 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: 18723283
• MDR Text Key: 336639551
• Report Number: 2029046-2024-00522
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31191125L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP