MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_LASSO

Catalog Number UNK_LASSO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 08/31/2002

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.Biosense webster manufacturer's report number: 2029046-2020-01233 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 12 patients underwent catheter ablation of atrial fibrillation and suffered pulmonary vein stenosis (moderate).Intervention was not reported.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is lasso.Other biosense webster devices that were also used in this study: none non-biosense webster devices that were also used in this study: chilli publication details title: use of intracardiac echocardiography for prediction of chronic pulmonary vein stenosis after ablation of atrial fibrillation objective: measurement of pv flows with ice before and after ablation has been proposed as a method for predicting which patients will develop chronic pv stenosis.However, this hypothesis has never been tested.Methods: consecutive patients who were referred to our laboratory for af ablation procedures were included in the study.Antiarrhythmic drugs and warfarin were discontinued five half-lives and 3 days before the ablation, respectively.Amiodarone was withdrawn 4 to 5 months before the procedure.For patients who presented in af on the day of the study, a transesophageal echocardiogram was done immediately before the ablation to exclude the presence of thrombus in the left atrium.

• Brand Name: UNK_LASSO
• 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: 10532887
• MDR Text Key: 206933579
• Report Number: 2029046-2020-01232
• Device Sequence Number: 1
• Product Code: DRF
• 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: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

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_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/14/2020
• 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): Required Intervention
• Patient Age: 52 YR