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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report numbers: 2029046-2021-00760, 2029046-2021-00761 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 1 patients underwent catheter ablation of atrial fibrillation and suffered hemorrhage.This adverse event was considered serious.Intervention was not reported (thermocool sf).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: carto 3, carto xp, carto rmt.Non-biosense webster devices that were also used in this study: none.Publication details: title: catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (attest).Objective: delay of progression from paroxysmal to persistent atrial fibrillation (af) is an important measure of long-term success of af treatment.However, published data on the impact of catheter ablation on af progression are limited.This study evaluates whether radiofrequency (rf) catheter ablation delays the progression of af compared with antiarrhythmic drug (aad) treatment using current af management guidelines.Methods: this prospective, randomized, controlled, two-arm, open-label trial was conducted at 29 hospitals and medical centres across 13 countries.Patients were randomized 1 : 1 to rf ablation or aad treatment.The primary endpoint was the rate of persistent af/atrial tachycardia (at) at 3 years.

• 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: 11829478
• MDR Text Key: 250813140
• Report Number: 2029046-2021-00762
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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: 04/29/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR