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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 05/05/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.Kim j, kim jy, jeong ds, chung tw, park sj, park km, kim js, lee jm, on yk.Long-term outcome of thoracoscopic ablation and radiofrequency catheter ablation for persistent atrial fibrillation as a de novo procedure.Europace.2023 may 5;25(5):euad096.Doi: 10.1093/europace/euad096.Epub ahead of print.Pmid: 37144277; pmcid: pmc10228598.Objective/methods/study data: the sought to compare the long-term efficacy of thoracoscopic ablation vs.Radiofrequency (rf) catheter ablation as the first procedure for persistent af.Between february 2011 and december 2020, 575 patients who underwent ablation for persistent af were studied.Among them, thoracoscopic ablation was performed in 281 patients, rf catheter ablation in 228, and hybrid ablation in 66.Rhythm, clinical, and safety outcomes during 7-year follow-up were compared.The patients who underwent thoracoscopic ablation were older, had a higher prevalence of stroke, and had a larger left atrial volume than those who underwent rf catheter ablation.In the propensity score-matched population (n = 306), incidences of atrial tachyarrhythmia recurrence were 51.4% in the thoracoscopic ablation group and 62.5% in the rf catheter ablation group [adjusted hazard ratio (hr) 0.869, 95% confidence interval (ci) 0.618¿1.223, p = 0.420].Stroke and total procedural adverse events were not significantly different between thoracoscopic and rf catheter ablation (2.7 vs.2.5%, p = 0.603, and 7.1 vs.4.8%, p = 0.374, respectively).The hybrid ablation group showed similar rhythm outcomes compared with both the thoracoscopic and the rf catheter ablation groups.At the redo procedure, pulmonary vein gaps were more frequently observed in the rf catheter ablation group (32.6%) than in the thoracoscopic ablation group (7.9%) and in the hybrid ablation group (8.8%) (p < 0.001).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: (thermocool smartouch, biosense webster inc., diamond bar, ca, usa.Other biosense webster devices that were also used in this study: carto3, biosense webster, (lasso nav, biosense webster), non-biosense webster devices that were also used in this study: lighted dissector (atricure lumitip dissector, atricure, cincinnati, oh, usa), bipolar ligasure instrument(medtronic, minneapolis, mn, usa), echelon flex 60 articulating endoscopic linear stapler (ethicon endo-surgery inc., cincinnati, oh, usa) or the atriclip pro device (atricure), adverse event(s) and provided interventions qty 22- percarditis- 10 in the thoracoscopic ablation group, 5 in the rf catheter ablation group and 5 in the hybrid ablation group- no intervention mentioned.Qty 1- cardiac tamponade in the rf catheter ablation - no intervention mentioned.Qty 2- surgical wound infection - 1 in thoracoscopic ablation group, 1 in hybrid ablation group- no intervention mentioned- coded as infection.Qty 4 - stroke - 2 in the thoracoscopic ablation group, 1 in the rf catheter ablation group and 1 in the hybrid ablation group- no intervention mentioned qty 2- surgical site bleeding requiring intervention- 2 in hybrid ablation.

Manufacturer Narrative

This complaint is from a literature source.Kim j, kim jy, jeong ds, chung tw, park sj, park km, kim js, lee jm, on yk.Long-term outcome of thoracoscopic ablation and radiofrequency catheter ablation for persistent atrial fibrillation as a de novo procedure.Europace.2023 may 5;25(5):euad096.Doi: 10.1093/europace/euad096.Epub ahead of print.Pmid: 37144277; pmcid: pmc10228598.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).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• 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: 17164109
• MDR Text Key: 317623402
• Report Number: 2029046-2023-01320
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Patient Outcome(s): Life Threatening