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 Transient Ischemic Attack (2109)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report number: 2029046-2021-00601 is 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 in the 2019 study cohort underwent catheter ablation of atrial fibrillation and suffered a transient ischemic attack (tia).Intervention was not reported.Model and catalog number are not available, but the suspected device is thermocool smarttouch sf.Other biosense webster devices that were also used in this study: lasso, (pentaray nav, carto 3 non-biosense webster devices that were also used in this study: 7-french 20-pole catheter (daig duodeca).Publication details: title: rebooting atrial fibrillation ablation in the covid-19 pandemic.Objective: catheter ablation procedures for atrial fibrillation (af) were significantly curtailed during the peak of coronavirus disease 2019 (covid-19) pandemic to conserve healthcare resources and limit exposure.There is little data regarding periprocedural outcomes of medical procedures during the covid-19 pandemic.We enacted protocols to safely reboot af ablation while limiting healthcare resource utilization.We aimed to evaluate acute and subacute outcomes of protocols instituted for reboot of af ablation during the covid-19 pandemic.Methods: perioperative healthcare utilization and acute procedural outcomes were analyzed for consecutive patients undergoing af ablation under covid-19 protocols (2020 cohort; n=111) and compared to those of patients who underwent af ablation during the same time period in 2019 (2019 cohort; n=200).Newly implemented practices included preoperative covid-19 testing, selective transesophageal echocardiography (tee), utilization of venous closure, and same-day discharge when clinically appropriate.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11691363
• MDR Text Key: 246301745
• Report Number: 2029046-2021-00600
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/29/2021

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: 03/29/2021
• Initial Date FDA Received: 04/19/2021
• 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
• Treatment: 7-FRENCH 20-POLE CATHETER (DAIG DUODECA); UNK_CARTO 3; UNK_LASSO; UNK_PENTARAY
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR