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 Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: liu j, guan w, guo j, li x, xia y, niu g, yao y.Optimization of superior vena cava isolation with aid of ablation index guidance.J cardiovasc electrophysiol.2023 sep;34(9):1820-1827.Doi: 10.1111/jce.16006.Epub 2023 jul 26.Pmid: 37493500.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: liu j, guan w, guo j, li x, xia y, niu g, yao y.Optimization of superior vena cava isolation with aid of ablation index guidance.J cardiovasc electrophysiol.2023 sep;34(9):1820-1827.Doi: 10.1111/jce.16006.Epub 2023 jul 26.Pmid: 37493500.Objective/methods/study data:introduction: to investigate the optimal range of quantitative ablation index (ai) value during superior vena cava (svc) electrical isolation by radiofrequency catheter ablation (rfca).Methods: first, in a development cohort of patients with atrial fibrillation (af), the rfca with 40 w was performed to complete svc isolation guided by the conduction breakthrough point from the right atrium to svc.Then, the range of ai value was calculated by offline analysis on different segments of svc.Lastly, for the validation of af patients, the safety and effectiveness of svc isolation with the optimized target range of ai value were evaluated with an additional adenosine test.Results: a total of 101 patients with af were included in the study (44 patients in the development cohort/57 in the validation cohort).The segmental ablation strategy was applied in 70% of the patients.According to the offline analysis of the ai values in the development cohort, the target ai value range was set as 350¿400.The success rate of svc isolation in the validation cohort was significantly higher than that in the exploration cohort (100% vs.90.9%, p =.02), and no complications occurred in the exploration cohort.During the adenosine test, the recovery rate of electrical conduction in svc was significantly lower than that in the pulmonary vein (3.5% vs.17.5%).Conclusion: the target ai value with a range from 350 to 400 is safe and effective for high-power rfca to complete svc isolation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: (smarttouch or smarttouch sf.Other biosense webster devices that were also used in this study: lasso mapping catheter, carto 3 system with visitag.Non-biosense webster devices that were also used in this study: adverse event(s) and provided interventions possibly associated with unidentified smarttouch ablation catheter: qty 1 pericardial effusion treated with pericardial puncture and drainage (cardiac tamponade, recognized procedural complication), qty 1 (pericardial effusion) treated conservatively (minor injury).

• 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: 17952933
• MDR Text Key: 325896963
• Report Number: 2029046-2023-02343
• 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: 10/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/17/2023
• 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
• Treatment: CARTO 3 SYSTEM WITH VISITAG; LASSO MAPPING CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention