MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMARTTOUCH BIDIRCT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Transient Ischemic Attack (2109); Laceration(s) of Esophagus (2398); Pericardial Effusion (3271); Pericarditis (4448)

Event Date 07/19/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: francke a, taha ns, scharfe f, schoen s, wunderlich c, christoph m.Procedural efficacy and safety of standardized, ablation index guided fixed 50 w high-power short-duration pulmonary vein isolation and substrate modification using the close protocol.J cardiovasc electrophysiol.2021 sep;32(9):2408-2417.Doi: 10.1111/jce.15158.Epub (b)(6) 2021.Pmid: 34252990.Objective/methods/study data: introduction: ablation index (ai)-guided ablation according to the close protocol is very effective in terms of chronic pulmonary vein isolation (pvi).However, the optimal radiofrequency (rf) power remains controversial.Here, we thought to investigate the efficiency and safety of an ai-guided fixed circumferential 50w high power short-duration (hpsd) pvi using the close protocol.Methods and results: in a single-center trial, 40 patients underwent randomized pvi using ai-guided ablation without esophageal temperature monitoring.In 20 patients a close protocol guided fixed 50w hpsd was followed irrespective of the anatomical localization.Twenty subjects were treated according to the close protocol with standard power settings (20w posterior and 40w roof and anterior wall).In addition, 80 consecutive patients were treated according to the hpsd protocol to gather additional safety data.All patients underwent postprocedural esophagogastroduodenoscopy to reveal esophageal lesions (edels).The mean total procedural time was 80.3 ± 22.5 in hpsd compared to control 109.1 ± 27.4 min (p <.001).The total rf-time was significantly lower in hpsd with 1379 ± 505 s versus control 2374 ± 619 s (p <.001).There were no differences in periprocedural complications.Edel occurred in 13% in the hpsd and 10% in the control group.Edel occurring in the 50w hsdp patients were smaller, more superficial, and had a faster healing tendency.Conclusion: a fixed 50w hpsd circumferential pvi relying on the ai and close protocol reduce the total procedure time and the total rf time, without increasing the complication rates.The incidence of edels was similar using 50w at the posterior atrial wall.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch surroundflown ablation catheter.Other biosense webster devices that were also used in this study: carto3, lasso catheters, smart-ablate rf generator, non-biosense webster devices that were also used in this study: abbott agilis medium curve sheaths, abbott brk needle.Adverse event(s) and provided interventions: there were nineteen adverse events reported: (15) esophageal lesions, (1) transient ischemic attack ( facial palsy which resolved within minutes and showed no correlation with magnetic resonance imaging findings), (2)pericardial effusion, (1) pericarditis (dressler's syndrome), the symptoms and effusions resolved after t.5 days of antiphlogistic treatment.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: francke a, taha ns, scharfe f, schoen s, wunderlich c, christoph m.Procedural efficacy and safety of standardized, ablation index guided fixed 50 w high-power short-duration pulmonary vein isolation and substrate modification using the close protocol.J cardiovasc electrophysiol.2021 sep;32(9):2408-2417.Doi: 10.1111/jce.15158.Epub (b)(6) 2021.Pmid: 34252990.Note: the literature article's electronic file size is too large to be attached and submitted.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 not provided by the customer.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14734321
• MDR Text Key: 294280811
• Report Number: 2029046-2022-01356
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/17/2022

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_SMARTTOUCH BIDIRCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/17/2022
• 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: ABBOTT AGILIS MEDIUM CURVE SHEATHS; ABBOTT BRK NEEDLE; CARTO3; LASSO CATHETERS; SMART-ABLATE RF GENERATOR
• Patient Outcome(s): Other