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 Pleural Effusion (2010)

Event Date 04/30/2019

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 5 patients underwent catheter ablation of atrial fibrillation and suffered moderate-to-severe pleural effusions requiring drainage.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 smarttouch¿, biosense webster other biosense webster devices that were also used in this study: carto 3, pentaray non-biosense webster devices that were also used in this study: none publication details title: intraprocedural arrhythmia termination as an end point for hybrid ablation in patients with long-standing persistent atrial fibrillation: a 2-year follow-up study objective: hybrid catheter and surgical ablation has emerged as an effective therapy for patients with persistent atrial fibrillation (af).The aims of this study were to evaluate the relationship between intraprocedural arrhythmia termination and the long-term outcomes of hybrid ablation in patients with long-standing persistent af.Methods: from may 2015 through april 2019, 50 patients with persistent af with a mean duration of 73.3 ± 62.1 (median 54) months underwent single-step hybrid ablation.Pulmonary vein isolation, left atrial posterior wall isolation and left atrial appendage excision or closure were performed through a left-sided thoracoscopic approach.Subsequently, all patients underwent high-density endocardial mapping and electrogram-based ablation with the end point of af termination.

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).Additional information was received from the corresponding author on 19-jul-2021 confirming that the reported adverse event was unrelated to bwi product.Upon further review, this complaint does not meet the criteria for medical device reporting since the adverse event was not related to bwi devices.Therefore, it has been deemed not reportable.No further reports will be forthcoming.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12089184
• MDR Text Key: 259408028
• Report Number: 2029046-2021-01007
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_CARTO 3; UNK_PENTARAY
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR