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 06/30/2002

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.

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 and suffered moderate pulmonary vein stenosis 50-70%.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: (acunave - acuson, a cool-tipped ablation catheter - ep technologies.Publication details: title: randomized study comparing combined pulmonary vein-left atrial junction disconnection and cavotricuspid isthmus ablation versus pulmonary vein-left atrial junction disconnection alone in patients presenting with typical atrial flutter and atrial fibrillation.Objective: ¿atrial flutter (afl) and atrial fibrillation (af) frequently coexist in the same patient.Recently it has been demonstrated that the triggers for both af and afl may originate in the pulmonary veins (pvs).We hypothesized that in patients with both af and typical afl, pulmonary vein¿left atrial junction (pv-laj) disconnection may eliminate both arrhythmias.Methods: consecutive patients with documented symptomatic af and typical afl were randomly assigned to have pv-laj disconnection combined with cavotricuspid isthmus (cti) ablation (group 1, n49) or pv-laj disconnection alone (group 2, n59).

• 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: 10540957
• MDR Text Key: 211687523
• Report Number: 2029046-2020-01246
• 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: 08/28/2020

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: 08/28/2020
• Initial Date FDA Received: 09/16/2020
• 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): Other
• Patient Age: 54 YR