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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/22/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that an error message was displayed on the carto 3 system that the carto 3 system needed to reload.The carto 3 system rebooted on its own.The caller stated that they were able to continue the study.The procedure continued.Fse (field service engineer) follow-up was requested for the issue.Dispatch approved by css tb.Software version confirmed 7.2.40.250.It was also reported that a steam pop occurred during the ablation of the cti (cavotricuspid ishmus) line.The caller stated that there were no effusions discovered when they checked on ice after the steam pop had occurred.The procedure was completed.It was also reported that while performing a post-check on the patient with ice (intracardiac echocardiography), a pericardial effusion was discovered.The caller reported that the patient had no visible symptoms.The caller reported that the medical intervention provided was a pericardiocentesis and that about 150 ccs of fluid was removed from the patient.The patient was reported to be in stable condition.The ablation catheter was unavailable for return.Note: the carto 3 system crash was unrelated to the adverse event.The case was on monday (b)(6) 2023.The event was discovered at the end of the case with ice and the physician believes it was due to a steam pop on the cti (cavotricuspid ishmus).The patient was kept in the hospital, and they were not sure if or when the patient was discharged.Generator is a smartablate sn: (b)(6) and an stsf was used.We used tag index as the visitag settings with normal surpoint settings.The medical team did not look at other visitag colors, and they do not have the catheter lot number or information.There was a transseptal with agilis and they believe a baylis wire.There was ablation performed and steam pop on cti line indicated by impedance spike.Normal flow rates for stsf were used and we had the graph, dashboard, vector and visitag.The steam pop occurred towards the end of the case during the cti line.It was a power control setting, and ablation stopped because of an impedance spike cutoff but they do not have the settings available.The error shown was the impedance spike cutoff on the generator that immediately stopped ablation and they do not know the exact time we were on ablation.They believed it was around 10 seconds or so into the ablation.No errors on the carto system itself.They later did a post-effusion check which is where the effusion was seen.Steam pop is not mdr-reportable.High impedance cut-off exceeded 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.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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).

• 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: 17160703
• MDR Text Key: 317461148
• Report Number: 2029046-2023-01314
• 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
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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: AGILIS SHEATH.; BAYLIS WIRE.; CARTO 3 SYSTEM.; SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male