MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Cardiac Tamponade (2226)

Event Date 05/14/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: ukita k, egami y, kawamura a, nakamura h, matsuhiro y, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, yano m, nishino m, tanouchi j.Impact of radiofrequency catheter ablation for atrial fibrillation in patients with left atrial enlargement.Heart vessels.2022 may 14.Doi: 10.1007/s00380-022-02094-z.Epub ahead of print.Pmid: 35567636.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: ukita k, egami y, kawamura a, nakamura h, matsuhiro y, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, yano m, nishino m, tanouchi j.Impact of radiofrequency catheter ablation for atrial fibrillation in patients with left atrial enlargement.Heart vessels.2022 may 14.Doi: 10.1007/s00380-022-02094-z.Epub ahead of print.Pmid: 35567636.Objective/methods/study data: little has been reported on the impact of radiofrequency catheter ablation (rfca) for atrial fbrillation (af) in patients with left atrial enlargement (lae).A total of 706 patients underwent an initial rfca for af between september 2014 and september 2019 in our hospital.These patients were categorized into two groups according to the pre-procedural left atrial diameter (lad) measured by transthoracic echocardiography (tte): lae group with lad=50 mm and non-lae group with lad<50 mm.We compared the patient characteristics, ablation procedures, and late recurrence of af (lraf, defned as a recurrence of atrial tachyarrhythmia between 3 and 12 months after the rfca) between the two groups.In addition, we performed follow-up tte at 12 months after rfca and investigated the factors associated with left atrium (la) reverse remodeling in each group.Lae group and non-lae group consisted of 155 and 551 patients, respectively.There were no significant differences in ablation procedures, procedure-related complications, and the incidence of lraf between the two groups.Furthermore, non-paf was identifed as an independent predictor of la reverse remodeling in lae group by multiple regression analysis (p=0.020).Rfca might be an efective and safe procedure even in patients with lad=50 mm, using the contemporary 3d-guided mapping and ablation technologies.Moreover, rfca can lead to la reverse remodeling in 1 year if they have non-paf before ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster concomitant devices that were also used in this study: carto3¿, biosense webster inc., diamond bar, ca, usa.Non-biosense webster concomitant devices that were also used in this study: beeat¿, japan lifeline co., tokyo, japan.8.5fr sl0, st jude medical, st.Paul, usa.Adverse event(s) and provided interventions: (1) cardiac tamponade, (1) stroke (cerebrovascular accident), (5) phrenic nerve injury (diaphragmatic paralysis) there was no mention of intervention provided.

• Brand Name: THERMOCOOL SMARTTOUCH
• 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: 14749404
• MDR Text Key: 294884522
• Report Number: 2029046-2022-01379
• 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: 06/20/2022

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_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/20/2022
• 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: 8.5FR SL0, ST JUDE MEDICAL, ST. PAUL, USA; BEEAT¿, JAPAN LIFELINE CO., TOKYO, JAPAN; UNK_CARTO 3
• Patient Outcome(s): Life Threatening