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

Catalog Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a when the catheter was removed from the patient¿s body, visual inspection revealed that that thrombus had adhered to the catheter (tip electrode, distal side).When ablating the anterior wall of the right pulmonary vein (rpv), an increase in impedance value was observed, so ablation was interrupted.The ablation was conducted again, but there was no improvement on impedance value.The catheter was removed from the patient's body, and visual inspection revealed that thrombus had adhered to the catheter.The catheter was replaced to complete the procedure.No adverse patient consequence was reported.Additional information was received, and it was reported that when the thrombus occurred, irrigation flow was kept low flow due to wrong setting.As the generator setting was for 4mm ablation catheter, it remained ¿low¿ irrigation flow during ablation.Heparinized normal saline was used.The rise in impedance is not mdr reportable as the change in impedance was not reported to exceed any cut off value and no error was displayed regarding impedance.The thrombus issue is mdr reportable.

Manufacturer Narrative

E1.Initial reporter phone:(b)(6).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).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a when the catheter was removed from the patient¿s body, visual inspection revealed that that thrombus had adhered to the catheter (tip electrode, distal side).When ablating the anterior wall of the right pulmonary vein (rpv), an increase in impedance value was observed, so ablation was interrupted.The ablation was conducted again, but there was no improvement on impedance value.The catheter was removed from the patient's body, and visual inspection revealed that thrombus had adhered to the catheter.The catheter was replaced to complete the procedure.No adverse patient consequence was reported.Additional information was received, and it was reported that when the thrombus occurred, irrigation flow was kept low flow due to wrong setting.As the generator setting was for 4mm ablation catheter, it remained ¿low¿ irrigation flow during ablation.Heparinized normal saline was used.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, pump, and pressure gauge test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No char, thrombus or clot residues were observed during the inspection.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.A pump and pressure gauge test were performed, and the device was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 31134490l number, and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.The potential cause of the thrombus or clot residues observed by the customer could be related to the low flow during the irrigation, due to wrong setting.Even when no thrombus residues were observed, the wrong settings could be related to the issue reported by the customer.Therefore, the customer complaint was confirmed.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.Flush the catheter with heparinized saline before insertion into the body.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.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.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 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: 18288489
• MDR Text Key: 330435354
• Report Number: 2029046-2023-02879
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 31134490L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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: SMARTABLATE GEN. KIT (JAPAN).; SMARTABLATE PUMP KIT (JAPAN).; UNK_CARTO 3.