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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Respiratory Failure (2484)

Event Date 10/19/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent an afib ¿ persistent ablation procedure with a thermocool® smart touch® s f bi-directional navigation catheter and suffered respiratory failure which required prolonged hospitalization.It was reported that after a persistent atrial fibrillation case has completed, it was noticed that the patient had hyper cardiac respiratory failure.The hyper cardiac respiratory failure was noticed when they had attempted to extubate the patient.The patient was given narcotics for back pain as well.The physician believes the hyper cardiac respiratory failure is due to the patient's underlying chronic obstructive pulmonary disease (copd).Patient was still intubated at the time of reporting.It is unknown at the time of the call, if the patient is in stable condition.The adverse event was discovered post use of biosense webster inc.(bwi) products.The physician¿s opinion on the cause of this adverse event was due to the patient¿s condition- underlying copd, hypo cardiac respiratory failure.The patient remained intubated for a longer period.The outcome of the adverse event was unknown.The patient required extended hospitalization because the patient negatively reacted to narcotics given to treat back pain.In response he was observed to have hypo cardiac respiratory failure.Other relevant history- copd.Generator information make, model, serial number was stockert gmbh, (b)(4).

Manufacturer Narrative

An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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® S F 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: 15813904
• MDR Text Key: 303799570
• Report Number: 2029046-2022-02852
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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 KIT-US
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Male