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
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: yadav r, satti di, malwankar j, lopez-silva c, xu l, liebow-feeser e, akhtar t, marine je, berger r, calkins h, spragg d.Pericarditis after catheter ablation for atrial fibrillation: predictors and outcomes.Jacc clin electrophysiol.2024 feb;10(2):262-269.Doi: 10.1016/j.Jacep.2023.09.026.Epub 2023 nov 29.Pmid: 38032577.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 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.Manufacturer's ref #: (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: yadav r, satti di, malwankar j, lopez-silva c, xu l, liebow-feeser e, akhtar t, marine je, berger r, calkins h, spragg d.Pericarditis after catheter ablation for atrial fibrillation: predictors and outcomes.Jacc clin electrophysiol.2024 feb;10(2):262-269.Doi: 10.1016/j.Jacep.2023.09.026.Epub 2023 nov 29.Pmid: 38032577.Objective/methods/study data: background: catheter ablation is a mainstay of atrial fibrillation (af) treatment.Acute pericarditis after ablation is 1 of the frequently observed complications.There is a significant lack of data on the incidence and predictors of postablation pericarditis.Objectives: this study examines the incidence, characteristics, and predictors of pericarditis after af ablation.Methods: patients undergoing af ablation from january 1, 2016, to march 31, 2022, at (b)(6) were prospectively enrolled in an af ablation registry.A clinical diagnosis of acute pericarditis was established in accordance with 2015 european society of cardiology guidelines by the presence of at least 2 of the following characteristics: pleuritic chest pain, friction rub, typical electrocardiographic changes, or pericardial effusion within 3 months after the ablation procedure.Results: of 1,540 patients who underwent af ablation, 57 patients (3.7%) developed acute pericarditis.Baseline clinical characteristics including age, sex, and body mass index were comparable between the pericarditis and nonpericarditis groups.The median time to symptom onset was 1 day.Electrocardiographic changes were observed in 34 (59.6%) patients, pericardial effusion developed in 7 (12%) patients, and the mean duration of medical treatment was 7 days (25th-75th percentile: 3-14 days).Most pericarditis cases were treated medically with disease-specific nonsteroidal anti-inflammatory drugs (100%) and colchicine (81%).Effusion with tamponade necessitating pericardiocentesis was observed in 4 (7%) patients.Radiofrequency (rf) ablation was performed in 869 (58.6%) patients in the nonpericarditis group and 39 (68.4%) patients with pericarditis; cryoballoon ablation was performed in 486 (32.8%) patients in the nonpericarditis group and 11 (19.3%) patients with pericarditis.Multivariable logistic regression analysis identified rf ablation (or: 2.09; 95% ci: 1.07-4.08; p = 0.03) as an independent predictor of acute pericarditis after af ablation, whereas age per unit increase was associated with a decreased risk (or: 0.97; 95% ci: 0.95-0.995; p = 0.02).Conclusions: the incidence of acute pericarditis after catheter ablation in our study population was 3.7%.Rf ablation and younger age were independent risk factors for postablation acute pericarditis.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter.Concomitant biosense webster devices that were used in this study: carto mapping system.Concomitant non-biosense webster devices that were also used in this study: arctic front advance cryo catheter (medtronic).Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: patient #1 68 yo male experienced (pericarditis)(recognized procedural complication) treated with ibuprofren and cochicine medications (patient event non serious).Patient #2 65 yo male experienced pericardial effusion treated with pericardiocentesis with 180 ml bloody fluid drained (cardiac tamponade)(recognized procedural complication).Patient #3 45 yo female experienced (pericarditis)(recognized procedural complication) treated with ibuprofren and cochicine medications (patient event non serious).Patient #4 73 yo female experienced (pericarditis)(recognized procedural complication) treated with ibuprofren and cochicine medications (patient event non serious).Patient #5 68 yo female experienced pericardial effusion treated with pericardiocentesis with 600 ml serosanguinous fluid drained (cardiac tamponade).(recognized procedural complication).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: 18936406
• Report Number: 2029046-2024-00922
• Device Sequence Number: 15214620
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCTIC FRONT ADVANCE CRYO CATHETER (MEDTRONIC); UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown