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

Catalog Number D134805

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

Patient Problem Respiratory Failure (2484)

Event Date 01/15/2024

Event Type  Death  

Manufacturer Narrative

Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 ref.# (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced respiratory failure requiring extended hospitalization and died.It was initially reported that the carto had a 1007 chest patch sensor error.The green and yellow cable were swapped and the issue followed the cable.The yellow sensor cable was replaced and the issue resolved.The customers sensor patch issue is not mdr reportable since this is highly detectable.After the cardiac ablation procedure, later that evening when the patient was recovering, the patient "coded", with respiratory failure and needed ventilation support.Additional information was later received indicating the patient coded multiple times the evening of (b)(6) 2024 through (b)(6) 2024.To reporter's understanding the patient received a chest x-ray and was ventilated due to respiratory failure.The patient required extended hospitalization due to respiratory failure and pulseless ventricular fibrillation (vf).The physician¿s opinion of the cause of the adverse event was the patient¿s condition was not stable enough for the procedure.The patient recently had 3 pulmonary embolisms prior to the procedure, patient was morbidly obese, and potentially other co-morbidities that reporter was unaware of leading up to the procedure.The caller stated that the physician did not believe the issue was due to any bwi products.

• 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: 18675841
• MDR Text Key: 335010936
• Report Number: 2029046-2024-00438
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNK_CARTO VIZIGO SHEATH; UNK_OCTARAY NAV; UNK_SOUNDSTAR
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female