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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Perforation (2513); Embolism/Embolus (4438)

Event Date 11/15/2022

Event Type  Death  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: wang y, zhao y, zhou k, zei pc, wang y, cheng h, chen s, tao y, mao y, liu q, bangash ab, sheng x, sun y, zhang p, yu l, lin j, zhang z, fu g, jiang r, jiang c.Intracardiac echocardiography is a safe and effective alternative to transesophageal echocardiography for left atrial appendage thrombus evaluation at the time of atrial fibrillation ablation: the ice-tee study.Pacing clin electrophysiol.2023 jan;46(1):3-10.Doi: 10.1111/pace.14601.Epub 2022 nov 15.Pmid: 36301182.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.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 reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: wang y, zhao y, zhou k, zei pc, wang y, cheng h, chen s, tao y, mao y, liu q, bangash ab, sheng x, sun y, zhang p, yu l, lin j, zhang z, fu g, jiang r, jiang c.Intracardiac echocardiography is a safe and effective alternative to transesophageal echocardiography for left atrial appendage thrombus evaluation at the time of atrial fibrillation ablation: the ice-tee study.Pacing clin electrophysiol.2023 jan;46(1):3-10.Doi: 10.1111/pace.14601.Epub 2022 nov 15.Pmid: 36301182.Objective/methods/study data: background: intracardiac echocardiography (ice) technology has been increasingly accepted as an integral part of atrial fibrillation (af) ablation procedures.It is still unknown whether ice can routinely replace transesophageal echocardiography (tee) for routine thrombus screening in non-selective af patients.Objective: to assess whether ice can routinely replace tee in screening for left atrial (la)/left atrial appendage (laa) thrombus in general patients undergoing catheter ablation for af.Methods: a total of 2003 consecutive patients undergoing af ablation were included.1155 patients (ice group) received intra-procedural ice examination for la/laa thrombus screening, while 848 patients (tee group) received pre-procedure tee examination.The incidence of thrombus, peri-procedure complications, and hospital efficiency were assessed.Results: the la and laa were adequately visualized in all patients.Five patients in the ice group and 15 patients in the tee group were found to have laa thrombus.The incidence of major periprocedural thrombo-embolic events was comparable between two groups (0.2% vs.0.1%, p =.76), none were due to undetected la/laa thrombus.Other major periprocedural complications occurred at similar rates in both groups, while post-procedure fever was less common in the ice group (12.7% vs.17.4%, p <.001).Procedure times and hospital length of stay were both shorter in the ice group (142 min [87-197 min] vs.150 min [95-205 min], and 3[2-4] day vs.4[3-5] day, respectively, both p <.001).Conclusions: ice can replace tee for atrial thrombus screening in af patients undergoing ablation without increased complications.An "ice replacing tee" workflow can also reduce the incidence of postoperative fever and improve hospital efficiency.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: carto mapping system, pentaray mapping catheter, soundstar ice catheter, lasso mapping catheter concomitant non-biosense webster devices that were also used in this study used in tee group: vingmed ultrasound as (general electric) the vascular access complications are associated with sheath usage and the article does not discuss/identify sheaths.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 5 (thrombosis)(recognized procedural complication qty 14 hemodynamically significant pericardial effusion that required pericardiocentesis(cardiac tamponade)(qty13 recognized procedural complication) with one requiring placement of a pericardial drain (qty 1 surgical intervention).Qty 3 strokes (cerebrovascular accident)(recognized procedural complication) qty 291 post-procedural fever (fever) with 53.6% showing low-grade and recovered.After rehydration and empiric anti-infective therapy (approximately qty 156 minor injury).And no information regarding the remaining cases (qty 155 insufficient information).Death adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 1 (cardiac perforation) requiring cardiac surgery (surgical intervention) and died (death) due to disseminated intravascular coagulation (embolism).

Manufacturer Narrative

On 26-mar-2024, additional information was received from the author of the article indicating there was no relevance between the harm and the bwi product in the article.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: 18938189
• MDR Text Key: 338066285
• Report Number: 2029046-2024-00932
• 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,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 03/26/2024
• 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: CARTO MAPPING SYSTEM; LASSO MAPPING CATHETER; PENTARAY MAPPING CATHETER; SOUNDSTAR ICE CATHETER; VINGMED ULTRASOUND AS (GENERAL ELECTRIC)
• Patient Outcome(s): Death