MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Pulmonary Edema (2020); Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Date 10/29/2021

Event Type  Death  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: reddy sa, nethercott sl, khialani bv, virdee ms.Pulmonary vein isolation for atrial fibrillation: does ablation technique influence outcome? indian heart j.2021 nov-dec;73(6):718-724.Doi: 10.1016/j.Ihj.2021.10.012.Epub 2021 oct 29.Pmid: 34743897; pmcid: pmc8642637.Objective/methods/study data: background: over the last 20 years various techniques have been developed striving for safer and more durable pulmonary vein isolation (pvi).The three most commonly used tools are pulmonary vein ablation catheter (pvac) and cryoballoon (¿single-shot¿ techniques), and point-by-point (pbp) radio frequency ablation using 3d electroanatomical mapping (eam).Objective: evaluate the safety and efficacy of the different techniques in an unselected population undergoing de-novo ablation for persistent or paroxysmal atrial fibrillation (af) at (b)(6).Method: retrospective, single-centre study of consecutive af ablations at rph between march 2017 and april 2018.Demographic, procedural and outcome data were analyzed.Results: over the study period 329 first-time pvi procedures were performed.37.4% were performed using pbp, 39.8% using cryoballoon and 22.8% using pvac.There was no significant difference in age or sex between different ablation technique groups.238 procedures were performed for paroxysmal af and 91 for persistent af.A higher proportion of the persistent cases were performed using point-by-point techniques compared to paroxysmal cases (58.2% vs 29.0%, p < 0.05).Procedural times were significantly longer in the group undergoing pbp ablation compared to cryoballoon or pvac.However, there was no statistically significant difference in 12-month freedom from symptomatic af or procedural complications between the groups.Conclusions: pbp, pvac and cryoballoon af ablation all appeared equally efficacious in an unselected population, though pvac and cryoballoon procedures were shorter.All procedures were associated with a low adverse event rate.Prospective examination is required to substantiate this finding.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch surround flow catheter.Other biosense webster concomitant devices that were also used in this study: carto; biosense webster.Non-biosense webster concomitant devices that were also used in this study: cryoballoon (medtronic, (b)(4)); pvac (medtronic, (b)(4)); acqmap (acutus medical, (b)(4)); achieve mapping catheter.Adverse event(s) and provided interventions: there were 5 adverse evens reported: one patient had to be admitted to intensive care post-procedure for respiratory support due to pulmonary edema, but made a full recovery to discharge.Two patients underwent pericardiocentesis for tamponade; one case manifested during ablation and led to procedure abandonment following drain insertion whilst the other case manifest soon after return to the ward.One case unfortunately resulted in atrio-esophageal fistula and death three weeks post-discharge.One case of transient ischemic attack occurring four days post discharge was reported at follow up, which manifest as transient slurring of speech and facial weakness lasting for approximately 1 h with spontaneous resolution.Brain imaging did not show any abnormality.A full neurological recovery was made with no recurrence.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: reddy sa, nethercott sl, khialani bv, virdee ms.Pulmonary vein isolation for atrial fibrillation: does ablation technique influence outcome? indian heart j.2021 nov-dec;73(6):718-724.Doi: 10.1016/j.Ihj.2021.10.012.Epub 2021 oct 29.Pmid: 34743897; pmcid: pmc8642637.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNK_THERMOCOOL SF NAV
• 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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14640945
• MDR Text Key: 293603933
• Report Number: 2029046-2022-01242
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: 05/20/2022
• 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: ACHIEVE MAPPING CATHETER; ACQMAP (ACUTUS MEDICAL, (B)(4)); CARTO, BIOSENSE WEBSTER; CRYOBALLOON (MEDTRONIC, (B)(4)); PVAC (MEDTRONIC, (B)(4))
• Patient Outcome(s): Life Threatening; Death; Required Intervention