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 Stroke/CVA (1770); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 02/02/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: costea, a, haile, b, barone, a, schenthal, m, romanowicz, k, rajsheker, s, et al.Porous tip radiofrequency ablation catheter reduced heart failure-related complications and healthcare resource utilization in paroxysmal atrial fibrillation patients.J arrhythmia.2023; 00: 1¿ 7.Https://doi.Org/10.1002/joa3.12830.Objective/methods/study data: this study aimed to evaluate the impact of contact force (cf) ablation with the porous tip on complications (congestive heart failure [chf] and non-chf related), healthcare resource utilization, and procedural efficiency in patients undergoing de novo paroxysmal atrial fibrillation (paf) ablations in a real-world setting.Methods: consecutive de novo paf ablations were performed between (b)(6) 2014 and (b)(6) 2019 by six operators at a single us academic center.The 6-hole design was used through (b)(6) 2016 with the 56-hole porous tip adopted in (b)(6) 2016.The outcomes of interest included symptomatic chf presentation and chf-related complications.Rf ablations were performed using the st between (b)(6) 2014 and (b)(6) 2016 or the stsf from (b)(6) 2016 onwards, both in conjunction with the carto visitag¿ module.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf catheter or thermocool smarttouch catheter.Other biosense webster devices that were also used in this study: carto.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional: qty 1 stroke (cerebrovascular accident) (considered serious injury).Qty 1 (pericardial effusion) with no intervention (considered minor injury).Qty 1 cardiac tamponade (recognized procedural complication).Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional sf: qty 11 (pericardial effusion) with no intervention (considered minor injury).Qty 2 (cardiac tamponade) (recognized procedural complication).

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.This complaint is from a literature source.The following literature cite has been reviewed: costea, a, haile, b, barone, a, schenthal, m, romanowicz, k, rajsheker, s, et al.Porous tip radiofrequency ablation catheter reduced heart failure-related complications and healthcare resource utilization in paroxysmal atrial fibrillation patients.J arrhythmia.2023; 00: 1¿ 7.Https://doi.Org/10.1002/joa3.12830.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: 17165143
• MDR Text Key: 317541144
• Report Number: 2029046-2023-01327
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 05/25/2023
• 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.
• Patient Outcome(s): Life Threatening