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

Catalog Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a redo atrial fibrillation (afib)ablation with a thermocool® smart touch¿ bi-directional navigation catheter and the patient experienced pain caused by a neurostimulator not working post procedure that required additional surgical intervention to get the neurostimulator replaced.In (b)(6)2023, the patient underwent a redo afib procedure.They already had a nuerostimulator implanted within them, a device that was switched off for the procedure per patient guidance.However, after the cardiac ablation occurred the neurostimulator stopped working.Patient was unable to receive pain relief from their neurostimulator since their re-do afib procedure.The pain was initially discovered nearly 4 months after their cardiac ablation procedure.A company representative suspected that the neurotransmitter may have been short-circuited from the radiofrequency (rf) circuit running through the battery pack.However, the cause of the neurotransmitter damage and the patient's subsequent pain has not been confirmed.Although there is no clear causality for the neurotransmitter not working, the possibility of bwi products contributing to the adverse event cannot be excluded.There is no information about the generator.The adverse event is being captured on the ablation catheter as that is what delivers rf ablation and possibly affected the neurostimulator.

Manufacturer Narrative

Note: for section e, there were no initial reporter details provided.Only the country of the event is available.Since no device has been received for analysis, 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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 18691375
• MDR Text Key: 335186032
• Report Number: 2029046-2024-00472
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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: CARTO 3 SYSTEM
• Patient Outcome(s): Required Intervention