MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Perforation of Esophagus (2399); Pericarditis (4448)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: andrade jg, champagne j, dubuc m, deyell mw, verma a, macle l, leong-sit p, novak p, badra-verdu m, sapp j, mangat i, khoo c, steinberg c, bennett mt, tang asl, khairy p; circa-dose study investigators.Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial.Circulation.2019 nov 26;140(22):1779-1788.Doi: 10.1161/circulationaha.119.042622.Epub 2019 oct 21.Pmid: 31630538.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 no lot number was provided by the customer.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: andrade jg, champagne j, dubuc m, deyell mw, verma a, macle l, leong-sit p, novak p, badra-verdu m, sapp j, mangat i, khoo c, steinberg c, bennett mt, tang asl, khairy p; circa-dose study investigators.Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial.Circulation.2019 nov 26;140(22):1779-1788.Doi: 10.1161/circulationaha.119.042622.Epub 2019 oct 21.Pmid: 31630538.Objective/methods/study data:advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (pvi) and minimize arrhythmia recurrence after atrial fibrillation (af) ablation.We randomly assigned 346 patients with drug-refractory paroxysmal af to contact force¿guided radiofrequency ablation (cf-rf; n=115), 4-minute cryoballoon ablation (cryo-4; n=115), or 2-minute cryoballoon ablation (cryo-2; n=116).Follow-up was 12 months.The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (af, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time.In this multicenter, randomized, single-blinded trial, cf-rf and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch or smarttouch surround flow; biosense webster used in cf-rf concomitant other biosense webster devices that were also used in this study: carto3; biosense webster, diamond bar, ca.Concomitant non-biosense webster devices that were also used in this study: cryoballoon arctic front advance; medtronic).Adverse event(s) and provided interventions" there were a total of three ae: pericarditis (1), esophageal perforation(1), cardiac tamponade requiring surgical intervention (1).The article does not provide information on the specific bwi catheter that caused these adverse events so only one catheter is documented.If further information is received it will reevaluated and addressed accordingly.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13987152
• MDR Text Key: 290785889
• Report Number: 2029046-2022-00708
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• 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: CARTO3, BIOSENSE WEBSTER, DIAMOND BAR, CA; CRYOBALLOON ARCTIC FRONT ADVANCE, MEDTRONIC)
• Patient Outcome(s): Life Threatening; Required Intervention