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 Pseudoaneurysm (2605)

Event Date 03/31/2019

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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report numbers: 2029046-2021-00551 and 2029046-2021-00553 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 2 patients underwent catheter ablation of atrial fibrillation and suffered access site pseudoaneurysms which was treated successfully with thrombin injections.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: lasso, pentaray, carto, visitag.Non-biosense webster devices that were also used in this study: none publication details: title: repeat catheter ablation for recurrent atrial fibrillation: electrophysiologic findings and clinical outcomes.Objective: atrial fibrillation (af) ablation is successful in 60%¿80% of optimal candidates, with many patients requiring repeat procedures.We performed a detailed examination of electrophysiologic findings and clinical outcomes associated with first repeat af ablations in the era of contact force-sensing radiofrequency (rf) catheters.Methods: we retrospectively studied patients who underwent their first repeat af ablations for symptomatic, recurrent af at our center between 2013 and 2019.All repeat ablations were performed using contact force-sensing rf catheters.Pulmonary vein (pv) reconnections at repeat ablation and freedom from atrial arrhythmia 1 year after repeat ablation were evaluated.We further assessed these findings based on af classification at the time of presentation for repeat ablation, index rf versus cryoballoon (cb) ablation, and duration (=3 versus <3 years) between index and repeat procedures.

• 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: 11645661
• MDR Text Key: 244848164
• Report Number: 2029046-2021-00554
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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: 03/23/2021
• 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): Required Intervention
• Patient Age: 64 YR