MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: jiang r, chen m, yang b, liu q, zhang z, zhang f, ju w, li m, sheng x, sun y, zhang p, yu l, chen s, zhu j, cheng h, fu g, tung r, jiang c.Intraprocedural endpoints to predict durable pulmonary vein isolation: a randomized trial of four post-ablation techniques.Europace.2020 apr 1;22(4):567-575.Doi: 10.1093/europace/euz301.Pmid: 32249915.Objective: the optimal procedural endpoint to achieve permanent pulmonary vein isolation (pvi) during ablation of atrial fibrillation (af) remains unknown.The purpose of this study was to compare the impact of prolonged waiting periods and adenosine triphosphate (atp) testing after pvi on long-term freedom from af.Methods/study data: in total, 538 patients (median age 61 years, 62% male) undergoing first-time radiofrequency ablation for paroxysmal af were randomized into four groups: group 1 [pvi (no testing), n = 121], group 2 (pvi+30min waiting phase, n = 151), group 3 (pvi+atp, n = 131), and group 4 (pvi+30minþatp, n = 135).The primary endpoint was freedom from af.Repeat mapping to assess for late pulmonary vein (pv) reconnection was performed in patients who remained af-free for >3 years (n = 46) and in those who had repeat ablation for af recurrence (n = 82).During initial procedure, acute pv reconnection was observed in 33%, 26%, and 42% of patients in groups 2, 3, and 4, respectively.At 36 months, no significant differences in freedom from af recurrence were observed among all four groups (55%, 61%, 50%, and 62% for groups 1, 2, 3, and 4, respectively; p = 0.258).Late pv reconnection was commonly observed, with a similar incidence between patients with and without af recurrence (74% vs.83%; p = 0.224).The authors concluded that intraprocedural techniques to assess for pv reconnection did not improve long-term success.Patients without af recurrence after 3 years exhibited similarly high rates of pv reconnection as those that underwent repeat ablation for af recurrence.The therapeutic mechanisms of af ablation may not be solely predicated upon durable pvi.Of note: two patients in the study died during the follow-up period.The authors specify that the deaths were not related to cardiac issues, the ablation procedure, or any bwi products.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: bwi navistar thermocool 3.5 mm tip irrigated ablation catheter.Bwi lasso circular mapping catheter.Other biosense webster devices that were also used in this study: bwi carto electronic mapping system.Non-biosense webster devices that were also used in this study: na.Adverse event(s) and provided interventions: 2 reports of acute cardiac tamponade managed without surgical intervention.1 report of pericardial effusion treated conservatively.3 reports of hematoma- treatment unspecified.5 reports of stroke or tia in the 3 year follow up period.Treatment was not specified, and it is unknown if the events were associated with the procedure.".

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: CARDIAC ABLATION 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12393796
• MDR Text Key: 273844870
• Report Number: 2029046-2021-01452
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• 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
• Patient Outcome(s): Other