MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_LASSO

Catalog Number UNK_LASSO

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiogenic Shock (2262)

Event Date 05/31/2018

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's report number: 2029046-2021-01234, 2029046-2021-01235, 2029046-2021-01237, 2029046-2021-01239, 2029046-2021-01244, 2029046-2021-01246, 2029046-2021-01247, 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 underwent catheter ablation of atrial fibrillation and suffered shock.Intervention was not reported.( lasso ).Model and catalog number are not available, but the suspected device is lasso.Other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: achieve catheter, arctic front, publication details title: treatment success and its predictors as well as the complications of catheter ablation for atrial fibrillation in a high-volume centre.Objective: catheter ablation for atrial fibrillation (af) is a standard procedure for maintaining sinus rhythm.The aim of this study was to evaluate treatment success and its predictors and to provide quality control data on complications and redo operations in a centre with an initially a low but currently high annual volume.Methods: data on patients (n=1,253) treated with catheter ablation for af in tays heart hospital between january 2010 and may 2018 was evaluated (n=1178 ablation-naïve patients and n=1514 af ablations).Comprehensive data on patient characteristics, treatment results, redo operations and complications were collected.Treatment success (maintenance of sinus rhythm at 1 year) was evaluated among patients residing within the hospital district (45% of the entire study population).

• Brand Name: UNK_LASSO
• 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: 12264465
• MDR Text Key: 264700013
• Report Number: 2029046-2021-01243
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 07/14/2021

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: No Information
• Device Catalogue Number: UNK_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/02/2021
• 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: 59 YR