MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/09/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: cui yk, dong jz, du x, hu r, he l, long dy, bai r, yu rh, sang ch, jiang cx, liu n, li sn, wang w, guo xy, zhao x, zuo s, tang rb, ma cs.Outcome of catheter ablation for paroxysmal atrial fibrillation in patients with stable coronary artery disease.Pacing clin electrophysiol.2022 sep;45(9):1032-1041.Doi: 10.1111/pace.14571.Epub 2022 aug 9.Pmid: 35866663.Objective/methods/study data: background: atrial fibrillation (af) and stable coronary artery disease (scad) frequently coexist.This study aimed to assess the long-term outcome of catheter ablation in patients with paroxysmal af and scad.Methods: in total, 12,104 patients with paroxysmal af underwent catheter ablation in the chinese atrial fibrillation registry between 2011 and 2019 were screened.A total of 441 patients with scad were matched with patients without scad in a 1:4 ratio.The primary endpoint was af recurrence after single ablation.The composite secondary endpoints were thromboembolism, coronary events, major bleeding, all-cause death.Results: over a mean follow-up of 46.0 ± 18.9 months, the recurrence rate in patients with scad was significantly higher after a single ablation (49.0% vs.41.9%, p =.03).The very late recurrence rate of af in the scad group was also significantly higher than that in the control group (38.9% vs.31.2%;p =.04).In multivariate analysis, adjusted with the female, smoking, duration of af, previous thromboembolism, copd, and statins, scad was independently associated with af recurrence (adjusted hr, 1.19 [1.02¿1.40], p =.03).The composite secondary endpoints were significantly higher in the scad group (12.70% vs.8.54%, p =.02), mainly due to thromboembolism events (8.16% vs.4.41%, p <.01).Conclusions: scad significantly increased the risk of recurrence after catheter ablation of paroxysmal af.The incidence of thromboembolic events after catheter ablation of paroxysmal af in the patients with scad was significantly higher than that in those without scad.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch concomitant biosense webster devices that were used in this study: carto, pentaray, lasso concomitant non-biosense webster devices that were also used in this study: n/a the adverse events pseudoaneurysm and inguinal hematomas are associated with sheath that was used for vascular access, however the identity of the sheath is unknown.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch: qty 5 cardiac tamponades with unknown intervention (cardiac tamponade, recognized procedural complication) (adverse event) qty 1 acute heart failure with unknown intervention (heart failure, recognized procedural complication) (adverse event) qty 2 stroke with unknown intervention (cerebrovascular accident, recognized procedural complication) (adverse event).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: cui yk, dong jz, du x, hu r, he l, long dy, bai r, yu rh, sang ch, jiang cx, liu n, li sn, wang w, guo xy, zhao x, zuo s, tang rb, ma cs.Outcome of catheter ablation for paroxysmal atrial fibrillation in patients with stable coronary artery disease.Pacing clin electrophysiol.2022 sep;45(9):1032-1041.Doi: 10.1111/pace.14571.Epub 2022 aug 9.Pmid: 35866663.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19192390
• MDR Text Key: 341157337
• Report Number: 2029046-2024-01375
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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: 03/28/2024
• 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; LASSO; PENTARAY
• Patient Outcome(s): Life Threatening