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

Catalog Number D134805

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 10/11/2023

Event Type  Injury  

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.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 reference number: (b)(4).

Event Description

It was reported that a patient underwent a redo ischemic vt (ventricular tachycardia) and pvi (pulmonary vein isolation) ablation procedure using thermocool smarttouch catheter.After the procedure, the patient experienced stroke.The procedure was performed under general aesthesia.The thermocool smarttouch was flushed through the procedurewith half saline for the vt (consultant aware that this was off label and accepted the risk) and changed to heparinized normal saline for the pvi.The octaray catheter and vizigo sheath were also flushed with heparinized normal saline.Act (activated clotting time) was monitored throughout the procedure, and heparin administered administered accordingly.Procedure carried out with no issue.Some time after the procedure, the patient had a stroke.The physician's opinion on the cause of this adverse event was patient condition.Patient was transferred to a stroke centre.The patient's condition improved.Regarding the user error on the thermocool smarttouch: irrigating with half saline for vt ablation was not specified usage of this device.Referencing the ifu (instructions for use) for the ablation catheter, it is instructed to always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.

• 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: 18096124
• MDR Text Key: 327673873
• Report Number: 2029046-2023-02584
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 10/13/2023
• 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: DECANAV CATHETER; OCTARAY CATHETER; SMARTABLATE GENERATOR; SOUNDSTAR CATHETER; VIZIGO SHEATH; WEBSTER QUAD CATHETER
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG