MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 2 patients underwent catheter ablation of atrial fibrillation and suffered cardiac tamponade.Intervention was not reported.Model and catalog number are not available, but the suspected device is thermocool smarttouch.Other biosense webster devices that were also used in this study: carto 3, lasso, pentray nav, visitag.Non-biosense webster devices that were also used in this study: daig duodeca 2-10-2.Publication details: title: multiple procedure outcomes for nonparoxysmal atrial fibrillation: left atrial posterior wall isolation versus stepwise ablation.Objective: to compare multiple-procedure catheter ablation outcomes of a stepwise approach versus left atrial posterior wall isolation (la pwi) in patients undergoing nonparoxysmal atrial fibrillation (npaf) ablation.Methods: two hundred twenty two consecutive patients with npaf underwent first-time ablation using a contact-force sensing ablation catheter utilizing either a stepwise (group 1, n = 111) or la pwi (group 2, n = 111) approach.The duration of follow-up was 36 months.The primary endpoint was freedom from atrial arrhythmia >30 s.Secondary endpoints were freedom from persistent arrhythmia, repeat ablation, and recurrent arrhythmia after repeat ablation.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 11803637
• MDR Text Key: 249927105
• Report Number: 2029046-2021-00740
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 04/20/2021
• 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
• Treatment: DAIG DUODECA 2-10-2; UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR