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 Problems Ischemic Heart Disease (2493); Unspecified Tissue Injury (4559)

Event Date 02/01/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: dilling-boer d, nof e, beinaert r, wakili r, heidbuchel h, koopman p, schurmans j, phlips t, didenko m, vijgen j.Damage to the left descending coronary artery due to radiofrequency ablation in the right ventricular outflow tract: clinical case series and anatomical considerations.J cardiovasc electrophysiol.2023 feb;34(2):468-477.Doi: 10.1111/jce.15816.Epub 2023 jan 19.Pmid: 36651349.Objective/methods/study data: the purpose of this paper was to highlight the importance of the anatomy of the right ventricular outflow tract (rvot) and the proximity of the mid segment of the left anterior descending coronary artery (lad) to the rvot in the setting of ablation of ventricular arrhythmias in the rvotauthors present a group of five patients from three centers between 2014 and 2017, who experienced occlusion/damage of the mid portion of the lad due to radiofrequency ablation of ventricular ectopy or ventricular tachycardia from the rvot and discuss the anatomical correlations predisposing to coronary damage in this region.All patients underwent percutaneous coronary intervention and stenting, four of them immediately during the same procedure and one 3 days later because of lack of signs and symptoms of acute coronary occlusion.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smart touch ablation catheter biosense webster devices that were also used in this study: carto system non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions possibly associated with a unknown smart touch bidirectional patient #1 43yo male experienced occlusion lad2 (arterial spasm) demonstrated by elevated readings (electrocardiogram st segment elevation) treated by stenting (surgical intervention) patient #2 39yo female experienced occlusion lad2 (arterial spasm) demonstrated by elevated readings (electrocardiogram st segment elevation) treated by stenting (surgical intervention) with additional device phenomenon noted (steam pop).Patient #3 58yo male experienced 50%¿70% lad2 stenosis (soft tissue injury) noted as not a spasm demonstrated by elevated readings (electrocardiogram st segment elevation) treated by stenting(surgical intervention) patient #4 65yo female experienced occlusion lad2 (arterial spasm) and reported chest (pain) demonstrated by elevated readings (electrocardiogram st segment elevation) treated by stenting (surgical intervention) patient #5 36yo female experienced occlusion lad2 (arterial spasm) and reported chest (pain)demonstrated by elevated readings (electrocardiogram st segment elevation) treated by stenting (surgical intervention).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: dilling-boer d, nof e, beinaert r, wakili r, heidbuchel h, koopman p, schurmans j, phlips t, didenko m, vijgen j.Damage to the left descending coronary artery due to radiofrequency ablation in the right ventricular outflow tract: clinical case series and anatomical considerations.J cardiovasc electrophysiol.2023 feb;34(2):468-477.Doi: 10.1111/jce.15816.Epub 2023 jan 19.Pmid: 36651349.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not 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.

• 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: 17168132
• MDR Text Key: 317645566
• Report Number: 2029046-2023-01333
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031/S053
• 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
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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?: Yes
• Date Manufacturer Received: 05/23/2023
• 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: CARTO SYSTEM
• Patient Outcome(s): Required Intervention