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

Model Number D134702

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

Patient Problem Respiratory Failure (2484)

Event Date 12/10/2021

Event Type  Death  

Event Description

It was reported that a male patient underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and patient expired the same day of the procedure upon arriving home.After the patient was discharged, the same day as their right atrial, typical flutter ablation, the patient collapsed in the driveway when they arrived home and subsequently expired.The patient's spouse reported that the patient experienced difficulty breathing on the way home or when they arrived home, before the patient expired.The physician did not believe the death was related to the ablation procedure.The patient had a history of chronic obstructive pulmonary disease (copd) and other health issues.The physician did not indicate that bwi equipment was responsible for the event.The procedure was uneventful, "textbook" and had no complications during or after the procedure.The case was completed and there were no errors or product malfunctions during the case.The physician did not feel there was any product related issue that could have led to the outcome.The procedure took 45 minutes and the patient had imaging done before to rule out any clot.Additional information received indicated the physician¿s opinion on cause of death is that it was either the patient¿s severe copd, a pericardial effusion (pe) or the patient condition as he was generally in poor health with copd.The patient¿s age was reported as mid 80¿s but exact age was not provided.This event will be conservatively reported for the patient¿s 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.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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13218880
• MDR Text Key: 283576993
• Report Number: 2029046-2022-00071
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• 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
• Patient Outcome(s): Death
• Patient Sex: Male