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 Problem Respiratory Failure (2484)

Event Date 04/27/2022

Event Type  Death  

Event Description

It was reported that a 64-year-old male male patient (191 pounds) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered respiratory distress and died.After completion of an afib case on 27-apr-2022 with no irregular issues or problems during the case; after returning back to the facility, the physician reported that the patient has expired.The procedure was completed successfully but waking up the patient was challenging but eventually was woken up.While the patient was in the recovery room, a stroke evaluation was performed and all checks were passed by the patient.The patient was sent to the icu for closer monitoring.Secondary to the anesthesia the patient went into respiratory distress in the icu and the patient expired.The patient had a medical history of chronic obstructive pulmonary disease (copd), chronic pericardial effusion - documented in h&p and present on tee prior to ablation, unchanged post procedure.In physician¿s opinion, what was the cause of death was hypercapnia respiratory distress as a result of general anesthesia.The procedure was completed without event.Patient woke with difficulty - experienced respiratory distress in recovery as well as in the unit.Stroke evaluation negative.Pericardial effusion unchanged from baseline.The generator used in the case was a smartablate.All deaths where bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14467507
• MDR Text Key: 292342365
• Report Number: 2029046-2022-01098
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Other
• Type of Report: Initial
• Report Date: 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2022
• 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: SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 64 YR
• Patient Sex: Male