MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D132701

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: yang c, yang j, liu q, you l, wu j, zhang y, wang l, xie r.The effect of different preoperative left atrial appendage emptying speeds on left atrial function in patients with persistent atrial fibrillation after left atrial appendage closure combined with catheter ablation.Bmc cardiovasc disord.2022 sep 6;22(1):399.Doi: 10.1186/s12872-022-02842-z.Pmid: 36068492; pmcid: pmc9450426.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 Description

This complaint is from a literature source.The following literature cite has been reviewed: yang c, yang j, liu q, you l, wu j, zhang y, wang l, xie r.The effect of different preoperative left atrial appendage emptying speeds on left atrial function in patients with persistent atrial fibrillation after left atrial appendage closure combined with catheter ablation.Bmc cardiovasc disord.2022 sep 6;22(1):399.Doi: 10.1186/s12872-022-02842-z.Pmid: 36068492; pmcid: pmc9450426.Objective and methods: objective: the present study aimed to investigate whether different preoperative left atrial appendage emptying speeds (laaevs) have an effect on left atrial function in patients with sinus arrhythmia after left atrial appendage closure (laac) combined with catheter ablation (ca).Methods: a total of 163 patients with persistent non-valvular atrial fibrillation who received combined laac+ca surgery were included in the present study.Regular follow-up was conducted for 12 months, and patients with complete data and successful sinus rhythm recovery were selected as the study subjects (n = 82).The patients were divided into two groups: the laaev < 25 cm/s group and the laaev = 25 cm/s group (n = 41 each).The propensity score was used for matching according to gender, age, cha2ds2-vasc score, and has-bled score.The changes in the two groups in la structure, storage function, conduit function, and pump function were compared.Results: before surgery, the maximum la volume (lavmax) and minimum la volume (lavmin) were greater in the laaev < 25 cm/s group than in the laaev = 25 cm/s group.The la storage function (eg.And srs), conduit function (eg.Sre), and pump function (eg.Sra) were all worse in the laaev < 25 cm/s group than in the laaev = 25 cm/s group.After the combined laac+ca surgery, the la storage, conduit, and pump functions improved in both groups.At 12 months after surgery, there were no statistically significant differences between the two groups.Conclusion: before combined laac+ca surgery, the la structure and function of the laaev < 25 cm/s group were worse than those of the laaev = 25 cm/s group.However, after laac+ca surgery, the la structure and function of the patients were improved, and there were no significant differences between the two groups.Inferred improvement in la structure and function in the laaev < 25 cm/s group was superior to that in the laaev = 25 cm/s group.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool st ablation 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: watchman devices (boston scientific).Adverse event(s) and interventions: 1 pericardial tamponade requiring percutaneous drainage; 1 acute left heart failure two days after the procedure treated with diuretics; 1 cerebral hemorrhage developed 3 months after the procedure treated conservatively.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: 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: 16433892
• MDR Text Key: 310131145
• Report Number: 2029046-2023-00371
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D132701
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• 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 3; WATCHMAN DEVICES (BOSTON SCIENTIFIC)
• Patient Outcome(s): Required Intervention; Life Threatening