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

Catalog Number	UNK_SMART TOUCH UNIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemoptysis (1887); Cardiac Tamponade (2226)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: lv j, wang r, yang j, you l, yang c, zhang y, liu q, yin l, liu jt, xie rq.Left atrial appendage closure in conjunction with radiofrequency ablation: effects on left atrial functioning in patients with paroxysmal atrial fibrillation.Open med (wars).2024 apr 12;19(1):20240951.Doi: 10.1515/med-2024-0951.Pmid: 38623457; pmcid: pmc11017190.Objective/methods/study data: objective in the present study, we investigated the impact of left atrial appendage closure (laac) following catheter ablation (ca) on the left atrial structure and functioning of patients with paroxysmal atrial fibrillation (af).Methods patients with paroxysmal af were enrolled in this single-center prospective cohort study between april 2015 and july 2021; 353 patients received ca alone, while 93 patients received ca in combination with watchman laac.We used age, gender, cha2ds2-vasc, and has-bled scores as well as other demographic variables to perform propensity score matching.Patients with paroxysmal af were randomly assigned to the ca combined with watchman laac group (combined treatment group) and the simple ca group, with 89 patients in each group.The left atrial structure, reserve, ventricular diastole, and pump functions and their changes in patients were assessed using routine doppler echocardiography and 2d speckle tracking echocardiography over the course of a 1-year follow-up.Results at 1-week follow-up, the reserve, ventricular diastole, and pump functions of the left atrium (la) increased in both groups; these functions were gradually restored at the 1- to 3-month follow-up; they were close to or returned to their pre-operative levels at the 3-month follow-up; and no significant differences were found compared with the preoperative levels at the 12-month follow-up.In the first 3 months, the reserve (, srs) and pump functions (sra) in the combined treatment group decreased significantly when compared with the simple ca group, and the differences were statistically significant.Conclusion patients with paroxysmal af may experience a short term, partial effect of laac on la reserve and pump functions, which are gradually restored and the effect disappears by 12 months.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, lasso concomitant non-biosense webster devices that were also used in this study: watchman boston scientific.Of note, there were some adverse events that occurred over 2 months post procedure that are not being associated with the catheter or procedure.In addition, vascular complications were reported that are associated with the sheath used for vascular access, however, the identity of the sheath was not provided.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch: qty 4 ¿ pericardial effusion during surgery but recovered normally after percutaneous drainage (cardiac tamponade)(recognized procedural complications); qty 1 ¿ patient developed a small amount of hemoptysis during surgery (hemoptysis)(major injury).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: lv j, wang r, yang j, you l, yang c, zhang y, liu q, yin l, liu jt, xie rq.Left atrial appendage closure in conjunction with radiofrequency ablation: effects on left atrial functioning in patients with paroxysmal atrial fibrillation.Open med (wars).2024 apr 12;19(1):20240951.Doi: 10.1515/med-2024-0951.Pmid: 38623457; pmcid: pmc11017190.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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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: 19633325
• Report Number: 2029046-2024-02144
• Device Sequence Number: 12612467
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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 UNIDIRECTIONAL
• 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: 05/31/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CARTO.; LASSO.; WATCHMAN BOSTON SCIENTIFIC.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown