MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 2029046-2020-00087 and 2029046-2020-00088 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿impact of preprocedural serum eicosapentaenoic acid to arachidonic acid ratio on post-ablation recurrence of atrial fibrillation¿ (pmid: 31735788).1 patient with atrial fibrillation who underwent first-time radiofrequency catheter ablation which was performed using an open-irrigated ablation catheter navistar thermocool developed sick sinus syndrome that required pacemaker implantation.The aim of this study was to examine the impact of the serum eicosapentaenoic acid (epa) to arachidonic acid (aa) ratio on recurrence after catheter ablation (ca) for atrial fibrillation (af).192 patients were enrolled.Patients were divided into two groups using the median serum epa/aa ratio.Patient characteristics, electrophysiological findings, and the incidence of af recurrence post ca were compared between the low and high groups.The principle strategy was extensive encircling pulmonary vein isolation (pvi) which was performed using an open-irrigated ablation catheter (navistar thermocool, biosense-webster, (b)(4), usa).We used the double-lasso technique under the guidance of a 3d mapping system (carto xp or carto3) bwi devices were used in this study.No devices specific information (including catalog and lot number) were provided in the article.Concomitant devices were: carto3 or carto xp mapping system.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: UNK_NAVISTAR THERMOCOOL
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 9587252
• MDR Text Key: 189504971
• Report Number: 2029046-2020-00089
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/14/2020
• 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): Required Intervention
• Patient Age: 60 YR