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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ischemic Heart Disease (2493)

Event Date 04/05/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a ventricular ectopic case with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered an electrocardiogram st segment elevation.During epicardial ablation, the patient had st elevation on the ecg.Additional information was received.The event was first discovered following the last of 5 ablations in the pericardial space near to a coronary artery.St changes indicating acute myocardial ischemia were noted on the 12 lead ecg.Upon reviewing carto replay data, it was noted that approx.30 secs into ablation no.4, 15secs of transient st changes occurred.These changes resolved during the ablation and did not occur again until after the last ablation.Physician¿s opinion on the cause of this adverse event was that as they were ablating in the pericardial space near to coronary arteries, the physician considers that this was a procedural complication not caused by any product malfunction.Coronary angiography was performed and intracoronary gtn given.They are not certain if coronary stenting was required.During the night following the procedure, the patient had low blood pressure (bp) and a liver hematoma secondary to dual anti platelet therapy but stabilized afterwards.Patient required extended hospitalization because of the adverse event as patient required at least an overnight stay following the coronary intervention.

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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: 16857036
• MDR Text Key: 314440438
• Report Number: 2029046-2023-00949
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK_CARTO 3
• Patient Outcome(s): Hospitalization