MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/30/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).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.Biosense webster manufacturer's report numbers : 2029046-2021-00810, and 2029046-2021-00813.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent catheter ablation for atrial fibrillation and suffered an embolic event.Intervention was not reported.Model and catalog number are not available, but the suspected device is thermocool smarttouch sf, biosense-webster other biosense webster devices that were also used in this study: carto 3 non-biosense webster devices that were also used in this study: tacticath(abbott), ensite navx, abbott publication details title: impact of diagnosis-to-ablation time on non-pulmonary vein triggers and ablation outcomes in persistent atrial fibrillation.Objective: non-pulmonary vein (pv) triggers are a major cause of atrial tachyarrhythmia (ata) recurrence after catheter ablation.However, the effect of the diagnosis-to-ablation time (dat) on non-pv triggers in persistent atrial fibrillation is unknown.Methods: his observational study evaluated 502 consecutive persistent af patients who underwent initial ablation.We compared 408 patients whose dat was <3 years with 94 patients whose dat was =3 years.Following pv and posterior wall isolation, 193 non-pv triggers, including 50 afs, 30 atrial tachycardias (ats), and 113 repetitive atrial premature beats, were elicited and ablated in 137 (27%) patients.Specifically, 80 non-pv af/at triggers were provoked in 64 (13%) patients, being identified more frequently in the dat¿=¿3 years group than in the dat¿<¿3 years group (20% vs.11%, p¿=¿.025) especially with a higher prevalence of coronary sinus/inferior left atrial triggers.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: UNK
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 11882399
• MDR Text Key: 256444002
• Report Number: 2029046-2021-00812
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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: 05/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR