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 Pulmonary Embolism (1498); Arrhythmia (1721); Transient Ischemic Attack (2109); Pericardial Effusion (3271)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: wang z, li j, chen j, guo h, he h, jiao s, chen y, dong j, sun y.Relationship between epicardial adipose tissue volume and recurrence after ablation in premature ventricular complexes.Circ j.2023 nov 1.Doi: 10.1253/circj.Cj-23-0474.Epub ahead of print.Pmid: 37914274.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).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: wang z, li j, chen j, guo h, he h, jiao s, chen y, dong j, sun y.Relationship between epicardial adipose tissue volume and recurrence after ablation in premature ventricular complexes.Circ j.2023 nov 1.Doi: 10.1253/circj.Cj-23-0474.Epub ahead of print.Pmid: 37914274.Objective/methods/study data: background: epicardial adipose tissue (eat) is recognized as a clinical diagnostic marker for cardiometabolic disease.Thicker eat may be associated with recurrence of ventricular tachycardia after ablation.The association between eat volume and recurrence of premature ventricular complexes (pvc) following ablation has not been clarified.Authors investigated the association between eat volume and pvc recurrence following radiofrequency catheter ablation.Methods and results: this retrospective study included 401 patients with pvc undergoing catheter ablation with preprocedural non-contrast computed tomography between 2017 and 2022.The impact of eat volume in predicting pvc recurrence after ablation was analyzed.The mean (±sd) age of patients was 50.2±13.3 years.Multivariable cox analysis revealed that a large eat volume was an independent predictor of pvc recurrence after ablation during a median follow-up of 16.3 months.Kaplan-meier analysis showed a difference in postablation pvc recurrence between the 2 groups dichotomized around the eat volume cut-off.The risk of recurrence increased with increasing eat volume according to restricted cubic spline regression.Furthermore, pvc originating from epicardial locations had larger eat volumes than those originating from the right ventricular outflow tract.Conclusions: a large eat volume was independently associated with pvc recurrence following ablation.Patients with pvc originating from epicardial sites had large eat volumes.Eat volume may help stratify patients according to their risk of pvc recurrence after ablation.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: n/a concomitant non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 1 atrioventricular block (heart block)(recognized procedural complication) qty 1 (pulmonary embolism)(recognized procedural complication) qty 2 (transient ischemic attack)(recognized procedural complication) qty 4 (pericardial effusion)(recognized procedural complication).

• 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: 18951499
• MDR Text Key: 338261689
• Report Number: 2029046-2024-00967
• Device Sequence Number: 1
• Product Code: LPB
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2024
• 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
• Patient Outcome(s): Life Threatening