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 Paralysis (1997); Unspecified Nervous System Problem (4426)

Event Date 03/31/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: yano m, egami y, kawanami s, sugae h, ukita k, kawamura a, nakamura h, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, nishino m, tanouchi j.Comparison of myocardial injury and inflammation between ablation index-guided and conventional contact force-guided ablation in atrial fibrillation patients.J interv card electrophysiol.2023 dec;66(9):2021-2030.Doi: 10.1007/s10840-023-01536-6.Epub 2023 mar 31.Pmid: 37000285.Objective/methods/study data: purpose: ablation index (ai)-guided ablation improves the incidence of arrhythmia recurrence as compared to conventional contact force (cf)-guided ablation.The aim of this study was to elucidate the differences in the biomarkers associated with myocardial injury and inflammation between conventional cf-guided and ai-guided ablation.Methods: atrial fibrillation (af) patients who underwent pulmonary vein isolation (pvi) from the osaka rosai atrial fibrillation ablation (oraf) registry were enrolled.We divided the patients into two groups: conventional cf-guided pvi (cf group) and ai-guided pvi (ai group).The differences in biomarkers associated with myocardial injury and inflammation, and long-term durability of pvi between the two groups were evaluated.Results: this study population included a total of 794 patients (cf-guided, 241 patients; ai-guided, 553 patients).Total application time was significantly shorter, and total application number was significantly smaller in ai than cf group.High-sensitive troponin i (hs-tni) post-ablation was significantly higher in ai than cf group (p < 0.001), even after taking the total application number and total application time into consideration.No significant differences in inflammatory markers changes from pre- to post-ablation were observed between the two groups.Ai-guided ablation was significantly associated with the hs-tni post-ablation by multiple regression analysis.The pv reconnection ratio was significantly smaller in ai than cf group (p = 0.037).Conclusions: ai-guided ablation had the ability to create larger lesions than cf-guided ablation despite no increase in inflammation and achieved the better pvi durability than that of cf-guided.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: carto3 mapping system.Non-biosense webster devices that were also used in this study: n/a.Pseudo aneurysm is associated with sheath usage and article does not provide identity of sheaths.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 4 phrenic nerve palsy (diaphragmatic paralysis)(recognized procedural complication) qty 9 gastroparesis (neurologic impairment) - article does not provide details regarding severity or interventions (insufficient information).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: yano m, egami y, kawanami s, sugae h, ukita k, kawamura a, nakamura h, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, nishino m, tanouchi j.Comparison of myocardial injury and inflammation between ablation index-guided and conventional contact force-guided ablation in atrial fibrillation patients.J interv card electrophysiol.2023 dec;66(9):2021-2030.Doi: 10.1007/s10840-023-01536-6.Epub 2023 mar 31.Pmid: 37000285.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).

• 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: 18924097
• MDR Text Key: 337904810
• Report Number: 2029046-2024-00882
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 02/21/2024
• 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: CARTO3 MAPPING SYSTEM.
• Patient Outcome(s): Other