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 01/12/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required prolonged hospitalization.The procedure occurred on (b)(6) 2024 and was completed without any problems, but three days later, on (b)(6), the doctor in charge reported that small amount of pericardial effusion was confirmed with the patient in the hospital ward.Drainage was not performed.The physician said that there might have been a place where the contact force was a little higher in 70th ablation at 50w on the posterior wall of the left cell.The event was determined to be a minor to moderate risk to the patient.The patient fully recovered and was discharged from the hospital on january 16.The patient required extended hospitalization because of the pericardial effusion.Transseptal puncture was performed with rf (radiofrequency) needle.No steam pop occurred or error messages were observed on biosense webster equipment during the procedure.Although no intervention was provided for the pericardial effusion, the reporter states that due to the adverse event, the patient required extended hospitalization.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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 31142105l and no internal action related to the complaint was found during the review.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: 18652193
• MDR Text Key: 334681280
• Report Number: 2029046-2024-00398
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 31142105L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2023
• 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: NGEN GENERATOR; UNK_CARTO 3; UNSPECIFIED PUMP; UNSPECIFIED RF NEEDLE
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male