MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number UNK_LASSO

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.Hassan ws, zaky sh, mohamed kh, ibrahim mm.Smart touch radiofrequency catheter ablation versus cryoballoon ablation of pulmonary veins in patients with paroxysmal atrial fibrillation.Open access maced j med sci.2020 aug 15; 8(b):563-568.Https://doi.Org/10.3889/oamjms.2020.444.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 not provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source.Hassan ws, zaky sh, mohamed kh, ibrahim mm.Smart touch radiofrequency catheter ablation versus cryoballoon ablation of pulmonary veins in patients with paroxysmal atrial fibrillation.Open access maced j med sci.2020 aug 15; 8(b):563-568.Https://doi.Org/10.3889/oamjms.2020.444.Objective/methods/study data: evaluation of the safety and efficacy of pulmonary veins isolation in patients with paroxysmal atrial fibrillation (af) using two new different technologies, cryoballoon (cb) ablation and radiofrequency ablation with contact force (cf)-sensing catheters.Prospective single-center evaluation, carried out from january 2016 to june 2018 in critical care medicine department ¿ cairo university, comparing cf radiofrequency (thermocool® smarttouch¿, biosense webster, inc.) (cf group) with cb ablation (arctic front advance 28 mm cb, medtronic, inc.) (cb group), in regards to procedural safety and efficacy, as well as recurrence at 12 months.Overall, 50 consecutive patients were enrolled (25 in each group).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster devices that were also used in this study: mapping catheter (cmc; lassotm; biosense webster) , cmc (lasso, biosense webster).Non-biosense webster devices that were also used in this study: 14-fr deflectable sheath(flexcath, medtronic) , circular achieve catheter (medtronic) , cryoballoon ablation catheter (medtronic).Adverse event(s) and provided interventions: qty 1 pericardial effusion and tamponade required surgical repair of the laa ( cf group).Qty 1 entrapment of circular mapping catheter into the mitral valve chordae required surgical intervention ( cf group).This event will be coded as soft tissue injury.

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15587898
• MDR Text Key: 301576340
• Report Number: 2029046-2022-02498
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

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?: Yes
• 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: 09/13/2022
• Initial Date FDA Received: 10/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 14-FR DEFLECTABLE SHEATH(FLEXCATH, MEDTRONIC).; CIRCULAR ACHIEVE CATHETER (MEDTRONIC).; CMC (LASSO, BIOSENSE WEBSTER).; CRYBALLON ABLATION CATHETER (MEDTRONIC).; MAPPING CATHETER (CMC, LASSOTM, BWI).
• Patient Outcome(s): Required Intervention