MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problems Pleural Effusion (2010); No Code Available (3191)

Event Date 02/26/2019

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: 2029046-2019-03338, 2029046-2019-03340, 2029046-2019-03342, 2029046-2019-03343 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: 2 patients underwent catheter ablation of atrial fibrillation and suffered hemothorax that required surgical revision.No additional details were provided.Multiple requests for clarification have been sent to the corresponding author, but no additional details were provided at this time.If additional details will be provided this report will be updated accordingly.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected devices is smarttouch thermocool sf.Other biosense webster devices that were also used in this study: smarttouch bidirectional.Non-biosense webster devices that were also used in this study: arctic front advance, flexcath advance; medtronic, satake hotballoon, toray, treswaltz, toray.Publication details: title: improvement in the quality of life of patients with persistent or long-standing persistent atrial fibrillation after hybrid ablation.Objective: to describe changes in the quality of life of patients with non-paroxysmal af before and after a hybrid ablation.Methods: seventy-five patients (49 men, age 62.9 ± 8.45 years, 48 (64%) with long-standing persistent af) were enrolled.Patients after hybrid ablation for persistent or long-standing persistent af were prospectively studied.Article received on: 26 february 2019.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 8741330
• MDR Text Key: 149625085
• Report Number: 2029046-2019-03341
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• 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: 63 YR