MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Pericardial Effusion (3271)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: veseli g, iwai s, jacobson jt.Survival of a patient with an esophagopericardial fistula after catheter ablation for atrial fibrillation: a case report and literature review.J innov card rhythm manag.2020 may 15;11(5):4091-4098.Doi: 10.19102/icrm.2020.110503.Pmid: 32461814; pmcid: pmc7244171.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 the 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 reference number:: (b)(4).

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: veseli g, iwai s, jacobson jt.Survival of a patient with an esophagopericardial fistula after catheter ablation for atrial fibrillation: a case report and literature review.J innov card rhythm manag.2020 may 15;11(5):4091-4098.Doi: 10.19102/icrm.2020.110503.Pmid: 32461814; pmcid: pmc7244171.Objective/methods/study data: a case of epf following radiofrequency catheter ablation for atrial fibrillation and an extensive review of the literature regarding catheter ablation¿related esophageal injury.A 59-year-old male was referred to the arrhythmia service in july 2017 for symptomatic persistent af.The patient was initially diagnosed with af in 2014, when he presented with palpitations.The patient¿s af was initially paroxysmal but progressed to persistent af in may 2017 and he was started on amiodarone 200 mg twice daily.Outpatient direct-current cardioversion (dccv) successfully restored sinus rhythm.The patient reported improvement for two days while in sinus rhythm but experienced a recurrence of exertional dyspnea and was found to be back in af.The echocardiogram result showed moderate to severe left ventricular dysfunction with an ejection fraction of 30% to 35% with global hypokinesis, mild right ventricular dysfunction, and a mildly dilated left atrium (la), with no significant valvular disease.Prior cardiac catheterization indicated nonobstructive coronary artery disease (cad).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch contact catheter other biosense webster devices that were also used in this study: carto 3 non-biosense webster devices that were also used in this study: cortrack tube (avanos) adverse event(s) and provided interventions (associated with ablation in the cf group): qty 1 - anterior and posterior pericardial effusion and required pericardiocentesis qty 1- esophageal fistula managed surgically.

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15566856
• MDR Text Key: 301481476
• Report Number: 2029046-2022-02434
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention