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 02/15/2024

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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 31185151l 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).

Event Description

It was reported a patient underwent an atrial tachycardia (at) cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and patient experienced pericardial effusion.Rf needle was used for transseptal puncture.Pulmonary vein isolation (pvi) was performed before pericardial effusion was identified.Four hours after the start of the procedure after la at mapping and before attempting eps and ablation with thermocool® smart touch® sf bi-directional navigation catheter, the blood pressure dropped and a mild pericardial effusion was observed in the posterior wall before attempting eps and ablation with thermocool® smart touch® sf bi-directional navigation catheter.The patient's blood pressure was quickly raised and controlled, but the procedure was terminated after considering that, as the effusion was at the posterior wall, drainage could not be performed if the effusion would increase.The cause was unknown as there was no evidence of high catheter contact.Activated clotting time (act) was difficult to prolong, and heparin was administered more than usual.No evidence of steam pop.Additional information was received.Vasopressors were administered, but pericardial drainage was not performed.No error messages observed on the biosense webster equipment during the procedure.The outcome of the adverse event was improved.The patient was discharged from the hospital on (b)(6) 2024 and did not require extended hospitalization.The physician¿s opinion on the cause of this adverse event was unknown.There was no evidence of high contact force of the catheter.Because act was difficult to prolong, heparin was administered more than usual.

• 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: 18861961
• MDR Text Key: 337179875
• Report Number: 2029046-2024-00772
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 31185151L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2023
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; CARTO 3 SYSTEM WITH CARTO MERGE; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; UNK GENERATOR; UNK PUMP; UNK RF NEEDLE
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 60 KG