MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; NAVISTAR® THERMOCOOL®

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Thrombosis (2100)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

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 no lot number was provided by the customer.(b)(4).

Event Description

This complaint is from a literature source.It was reported that 6 patients in the group (creatinine clearance (crcl) level at baseline more than 80 ml/min) underwent radiofrequency ablation for atrial fibrillation and suffered thromboembolic events.Title: ¿renal function and risk of stroke and bleeding in patients undergoing catheter ablation for atrial fibrillation: comparison between uninterrupted direct oral anticoagulants and warfarin administration.¿ the purpose of this study was to evaluate the safety and efficacy of periprocedural uninterrupted direct oral anticoagulant (doac) use compared with those of uninterrupted warfarin use in patients undergoing catheter ablation for af stratified by various renal function groups.2091 patients were enrolled in this study.The study was conducted from january 9, 2008 to march 31, 2017.An open-irrigated ablation catheter was used in this study, however catalog and lot number were unknown.Navistar thermocool catheter was chosen for documentation purpose.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7555426
• MDR Text Key: 109619887
• Report Number: 2029046-2018-01610
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/09/2018

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: 05/09/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR