MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

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.Biosense webster inc.'s reference number: (b)(4) has a report for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter) (2) importer report number # 2029046-2023-50008.Product code m490008 (smartablate¿ system irrigation pump (us).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system irrigation pump (us) and the patient experienced a cerebrovascular accident.It was reported that the ablation device failed to alarm low fluid level.When air was visualized in line behind liquid, the line did shut down when the air sensed.Patient suffered post operative stroke.Multiple attempts have been made to obtain additional information and clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

On 11-may-2023, additional information about the patient and event was received.It was reported that the adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was air in line which had the potential to result in patient¿s post procedure stroke.Intervention included the machine being shut off.The equipment was exchanged, the patient is receiving ongoing care for stroke.The patient¿s outcome from the adverse event was reported as improved.Patient required extended hospitalization because of the adverse event as patient required follow up stroke care and monitoring post cardiac ablation.A smartablate generator was used in this case with the correct catheter settings selected on the generator and the smartablate irrigation pump switching was from "low" to "high" flow during ablation.There was no evidence of char during the procedure.No evidence of blood thrombus / clot during the procedure.The sensor correctly identified presence of air in the circuit, alarmed, and shut off the irrigation pump.However, air was present in the line distal to the bubble sensor.The smartablate generator continued to show fluid remaining, though the full liter bag was empty.Device evaluation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.The device investigation has been completed which included performing a manufacturing record evaluation (mre).The 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed the information reported in section "e4.Reporter also sent report to fda?" of the 3500a initial mdr was incorrect as ¿unknown¿.It should have been ¿yes¿ as such, the field has now been updated.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 16635963
• MDR Text Key: 312236504
• Report Number: 2029046-2023-00663
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; SMARTABLATE REMOTE SPARE-US
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG