MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV

Catalog Number UNK_THERMOCOOL SF NAV

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/09/2018

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 lot number was provided by the customer.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2019-03515 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 3 patients underwent catheter ablation of atrial fibrillation and suffered hemorrhage.Intervention was not reported, but major hemorrhage was defined in the article as either fatal bleeding, and/or symptomatic bleeding in a critical area or organ, bleeding requiring a transfusion of 2 or more units of whole blood or red cells.No additional details were provided.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is thermocool sf.Other biosense webster devices that were also used in this study: none.Non-biosense webster devices that were also used in this study: none.Publication details: title: feasibility and safety of uninterrupted apixaban in patients undergoing radiofrequency ablation for atrial fibrillation.Objective: his study aimed to evaluate the safety and efficacy of uninterrupted apixaban in patients undergoing radiofrequency ablation for af.Methods: this was a prospective and nonrandomized cohort study.A total of 259 consecutive patients who underwent af ablation were evaluated.Received: 9 june 2018.

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: UNK
• 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: 8867018
• MDR Text Key: 153840919
• Report Number: 2029046-2019-03514
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 07/16/2019

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_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/06/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR