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 Problem Pericardial Effusion (3271)

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required prolonged hospitalization.While panning through with the soundstar® catheter, a pericardial effusion was noticed on intracardiac echocardiography.Once it was discovered, the medical team asked anesthesia if there were any changes in the blood pressure.At that point, anesthesia noticed a very small pressure drop but they treated based on their discovery on ice.The medical team monitored the effusion for approximately 15 minutes and noticed that it was not getting bigger so the decision was to leave it.The medical team was not not completely sure how the effusion happened, since there was no indication from carto® 3 or the generator that there was any issue.There was no high-force warning or impedance issue.There was no evidence of steam pop according to the physician, and no error messages observed on biosense webster equipment either.The physician stated that the cause of the adverse event was procedural since the issue may have occurred during the intubation or the placing of the temp probe or possibly even as a reactionary inflation from the ablation.Intervention only included monitoring for 25+ minutes but patient was admitted to icu.Effusion was unchanged after 25+ minutes of monitoring.The patient was reported to be in stable condition.Although no invasive medical intervention was done for the pericardial effusion, the patient did require a stay in icu, thus making this a reportable event.

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 (b)(6) 2024, the product investigation was completed as the complaint device was not returned for analysis.Since no device has been received for analysis, 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 31185779l 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.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: 18669025
• MDR Text Key: 334909720
• Report Number: 2029046-2024-00422
• Device Sequence Number: 1
• Product Code: LPB
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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: 31185779L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2023
• 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: BAYLIS VERSACROSS WITH STEERABLE SHEATH; CARTO 3 SYSTEM WITH VISITAG; NGEN GENERATOR; SOUNDSTAR ECO CATHETER; UNSPECIFIED PUMP
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 107 KG