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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC LASSO¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING Back to Search Results
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.
 
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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 Key15587898
MDR Text Key301576340
Report Number2029046-2022-02498
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeEG
Number of Events Reported1
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 NumberUNK_LASSO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2022
Initial Date FDA Received10/12/2022
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 Number1
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;
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