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 Transient Ischemic Attack (2109)

Event Date 08/31/2018

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 1 patient underwent catheter ablation of atrial fibrillation and suffered tia.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: lasso, carto 3 non-biosense webster devices that were also used in this study: agilis nxt.Publication details: title: radiofrequency versus cryoballoon catheter ablation for paroxysmal atrial fibrillation: durability of pulmonary vein isolation and effect on atrial fibrillation burden.Objective: recurrent paroxysmal atrial fibrillation (af) after catheter ablation is presumably caused by failure to achieve durable pulmonary vein isolation (pvi).The primary methods of pvi are radiofrequency catheter ablation (rf) and cryoballoon catheter ablation (cryo), but these methods have not been directly compared with respect to pvi durability and the effect thereof on af burden (% of time in af).Methods: accordingly, we performed a randomized trial including 98 patients (68% male, 61 [55¿67] years) with paroxysmal af assigned 1:1 to pvi by contact-force sensing, irrigated radiofrequency catheter, or second-generation cryoballoon catheter.Implantable cardiac monitors were inserted =1 month before pvi for assessment of af burden and recurrence, and all patients, irrespective of af recurrence, underwent a second procedure 4 to 6 months after pvi to determine pvi durability.

• 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
• 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: 12047008
• MDR Text Key: 257684304
• Report Number: 2029046-2021-00972
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030031/S053
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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: 06/03/2021
• 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: AGILIS NXT; UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR