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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ¿ paroxysmal ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac tamponade that required surgical intervention.It was reported that during the use of biosense webster inc.(bwi) products and during flouroless afib ablation, the patient suffered a pericardial effusion.After successfully mapping and ablating the left-sided pulmonary veins (waca line), while the physician was on the roof area of the right-sided pulmonary veins, the anesthesiologist alerted the physician that the patient was hypotensive with a decreased heartrate.Intracardiac echo (acunav catheter) revealed the pericardial effusion.The rapid response team was called and cpr was started because of the patient's low blood pressure.The bwi representative left the lab at this point as not to hinder interventional measures.A pericardiocentesis was performed removing 1000 ml of fluid from around the patient's heart.The patient received a blood infusion and was transported to cardiothoracic (ct) surgery.The physician¿s opinion on the cause of the event was that it was procedure related; however, it is unclear of what the cause was.The patient¿s condition improved and was in the hospital the next day; however, no further information was provided.Thermocool smarttouch sf catheter was used with force visualization features including graph, dashboard, vector and visitag.Parameters for stability used were 3 mm tags, 25% force over time of 3 sec 3mm range 3 sec.No additional filter used with visitag.Color options used: impedance drop.Transseptal puncture was performed with baylis needle.No evidence of steam pop.Irrigated catheter flow settings were 2ml low and 15 ml high.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31076041l and no internal action related to the complaint was found during the review.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).

• 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: 17725493
• MDR Text Key: 323129538
• Report Number: 2029046-2023-02045
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31076041L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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 GENERATOR KIT-US; UNK_ACUNAV; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 109 KG