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

Catalog Number SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stenosis (2263); Heart Block (4444)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: miyazaki y, ueda n, otsuka f, miyamoto k, noguchi t, kusano k.Rescue percutaneous coronary intervention for sinus node dysfunction following left atrial flutter ablation.Heart rhythm case rep.2021 may 4;7(8):529-532.Doi: 10.1016/j.Hrcr.2021.04.015.Pmid: 34434701; pmcid: pmc8377260.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: miyazaki y, ueda n, otsuka f, miyamoto k, noguchi t, kusano k.Rescue percutaneous coronary intervention for sinus node dysfunction following left atrial flutter ablation.Heart rhythm case rep.2021 may 4;7(8):529-532.Doi: 10.1016/j.Hrcr.2021.04.015.Pmid: 34434701; pmcid: pmc8377260.Objective/methods/study data: perimitral flutter (pmfl) is a common arrhythmia after ablation of atrial fibrillation.In some cases of pmfl, an anterior line is selected instead of the mitral isthmus line owing to technical and anatomical issues.1,2 in such cases, the sinus nodal artery (sna) courses high on the anterior left atrium (la) and is close to the block line on the anterior wall of the la.3 hence, the sna could be injured by radiofrequency (rf) ablation leading to sinus node dysfunction (snd).4,5 percutaneous coronary intervention (pci) for snd due to sna occlusion after stent implantation has been reported.However, few reports have shown the efficacy of the interventional strategy for sna injury after rf application.They report a case of snd following rf application on the anterior wall of the la that was successfully managed using pci for the occluded sna.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf; biosense-webster, inc.Other biosense webster devices that were also used in this study: pentaray; biosense-webster.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: a few minutes after the final rf application, sinus rhythm disappeared and junctional rhythm (heart block) appeared without significant st changes.Subsequently, pci was performed to the occluded site of the sna (coronary artery stenosis).Snf recovered immediately after pci, allowing termination of the dopamine infusion.

Manufacturer Narrative

On september 7, 2022 additional information was received clarifying that this event was previously reported to the fda under manufacturer report number: 2029046-2021-00343/manufacturer¿s reference number: (b)(4).As such this complaint is considered to be a duplicate.Any other information or updates will be reported to the fda under manufacturer report number: 2029046-2021-00343/manufacturer¿s reference number: (b)(4).Manufacturer¿s reference number: (b)(4).

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14696920
• MDR Text Key: 294934569
• Report Number: 2029046-2022-01319
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/20/2022
• 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: UNK_PENTARAY
• Patient Outcome(s): Required Intervention