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

Catalog Number D134805

Device Problems Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a non-ischemic ventricular tachycardia (non-isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there no irrigation coming out of the tip of the catheter during use on patient.During ventricular tachycardia (vt) ablation, after ablating in the left ventricle (lv) with a retrograde aortic approach, the physician removed the thermocool® smart touch® sf bi-directional navigation catheter (stsf) from the patient¿s body as he wanted to place the stsf in the right ventricle (rv) for some ablation.When the catheter was removed, the physician noticed that there was char on the tip of the catheter.Also, when trying to irrigate the catheter on high flow, the physician mentioned that there was no irrigation coming out of the tip of the catheter.The catheter was wiped and then flushed at high rate.The irrigation was not coming out of all the ports, so the bwi representative recommended to use a new stsf catheter.The catheters were changed and the procedure was successfully completed.There was no patient complication.A 4 minute procedure delay occurred.The physician was ablating at 35w in the lv using power control-mode on the smartablate generator.Default settings we used.No errors on the smartablate generator.The stsf was properly irrigated throughout the procedure and automatically went on high flow at 15cc during radio frequency (rf).

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.# pc-(b)(4).

Manufacturer Narrative

It was reported that a patient underwent a non-ischemic ventricular tachycardia (non-isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there no irrigation coming out of the tip of the catheter during use on patient.During ventricular tachycardia (vt) ablation, after ablating in the left ventricle (lv) with a retrograde aortic approach, the physician removed the thermocool® smart touch® sf bi-directional navigation catheter (stsf) from the patient¿s body as he wanted to place the stsf in the right ventricle (rv) for some ablation.When the catheter was removed, the physician noticed that there was char on the tip of the catheter.Also, when trying to irrigate the catheter on high flow, the physician mentioned that there was no irrigation coming out of the tip of the catheter.The catheter was wiped and then flushed at high rate.The irrigation was not coming out of all the ports, so the bwi representative recommended to use a new stsf catheter.The catheters were changed and the procedure was successfully completed.There was no patient complication.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation and pump and pressure gage test of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device; however, according to the picture provided by the decontamination site, char residues were observed in the tip of the device.A pump and pressure gage tests were performed, and the device was irrigating correctly.No irrigation issues were observed; however, further investigation revealed char material partially occluding the irrigation holes.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed since char material was observed partially occluding the irrigation holes.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and an 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 ref.# (b)(4).

Manufacturer Narrative

On 29-nov-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# pc-001474544.

• 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: 18188739
• MDR Text Key: 328958659
• Report Number: 2029046-2023-02741
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31110844L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 12/05/2023
• Supplement Dates FDA Received: 12/05/2023; 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• 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: CARTO 3 SYSTEM.; SMARTABLATE GENERATOR KIT-WW.; SMARTABLATE PUMP KIT-WW.