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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Tachycardia (2095)

Event Date 11/10/2022

Event Type  Death  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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).

Event Description

It was reported that a male patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered pleural effusion and died.Physician was using an ablation catheter in a ventricular tachycardia case, when a pleural effusion took place.The cardiothoracic surgeon took over, opened the patient¿s chest and repaired the heart muscle wall.Two hours after the operation the patient passed away from a disseminated intravascular coagulation.Surgery was delayed for 30 mins due to the reported event.Action taken when event occurred was that patient went to icu to recover however passed away 2 hours later.Procedure was not successfully completed.No fragments generated.Ep part of the operation was not completed as a surgeon had to perform open heart surgery to repair the heart wall.Patient consequence- patient passed away.Medical intervention -open heart surgery.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

On 20-dec-2022, bwi received additional information regarding the event.The adverse event occurred on 10 november 2022.The adverse event was discovered: before use during the procedure.Both cardiac surgeons worked to stabilize the patient.Cardio thoracic surgeon performed open heart surgery.Patient did not require extended hospitalization because of the adverse event because he passed that evening.Generator make/ model: m4900106, serial number: (b)(6).A thermocool® smarttouch® sf catheter was used.Parameters for stability for the visitag module used was 40w/ range from 30- 60 seconds.The medical team wasn't sure if date of death was 10/11 november.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 26-may-2023, the product investigation was completed as the complaint device was not returned.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 30850738l 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: 15907989
• MDR Text Key: 304732664
• Report Number: 2029046-2022-03030
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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
• Device Lot Number: 30850738L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2022
• 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.
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Sex: Male