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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/17/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced thrombosis.It was reported that during ablation there were no electrograms on the carto 3 system and the recording system.They stated that they removed the catheter from the body, and they noticed char on the tip of the catheter.They also noticed on ultrasound there was a 1cm clot on the posterior wall of the la.They were unaware of the clot before the procedure.They tried to aspirate the clot and they were able to remove the clot.They continued the procedure with a new catheter.The patient did not have any neurological issues and was alert once they were awake.No other medical intervention needed to be provided.They will return the catheter for analysis.The patient is at home.Char is not mdr-reportable.Bad/partial ecg is not mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

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 reference number: (b)(4).

Manufacturer Narrative

On 21-feb-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced thrombosis.It was reported that during ablation there were no electrograms on the carto 3 system and the recording system.They stated that they removed the catheter from the body, and they noticed char on the tip of the catheter.They also noticed on ultrasound there was a 1cm clot on the posterior wall of the la.They were unaware of the clot before the procedure.They tried to aspirate the clot and they were able to remove the clot.They continued the procedure with a new catheter.The patient did not have any neurological issues and was alert once they were awake.No other medical intervention needed to be provided.They will return the catheter for analysis.The patient is at home.Device evaluation details: a picture was received from the decontamination site on which the char was visible.Visual analysis revealed that the device had char on the tip area.Per the event, several tests were performed.The magnetic, electrical, and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating.The temperature and impedance test was performed, and no temperature was displayed due to an open circuit on the tip area.A manufacturing record evaluation was performed for the finished device [30957890l] number, and no internal actions related to the reported complaint condition were identified.  the char issue reported by customer was confirmed due to condition of the device.Char is a expected condition of the radiofrequency.The bad/partial ecg issue could not be replicated during the investigation.The no temperature readings failure is not related to the customer complaint and it could be related to the manipulation of the device after procedure.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 16372854
• MDR Text Key: 309500742
• Report Number: 2029046-2023-00292
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30957890L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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; CARTO VISITAG MODULE
• Patient Outcome(s): Life Threatening; Required Intervention