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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 12/31/2014

Event Type  Injury  

Manufacturer Narrative

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.Concomitant products that used in this study: carto, lasso.Non-biosense webster devices that were also used in this study: none.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2018-02466, 2029046-2018-02467.Are related to the same incident.(b)(4).

Event Description

"event description: this complaint is from a literature source.The following complications were reported in this publication: 1 patient underwent fluorless catheter ablation of atrial fibrillation and suffered partial phrenic nerve injury, with significant recovery at 9-month follow up.No further details were provided.Multiple requests for clarification have been sent to the corresponding author, but no additional details were provided at this time.If additional details will be provided this report will be updated accordingly.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 thermocool.Other biosense webster devices that were also used in this study: carto, lasso.Non-biosense webster devices that were also used in this study: none.Publication details- title: outcomes of 200 consecutive, fluoroless atrial fibrillation ablations using a new technique.Objective: a technique was developed to eliminate radiation exposure for routine atrial fibrillation (af) ablation, to simplify the procedure and to achieve cost effectiveness.We here report the outcomes of this approach.Methods: from 8/2016 to 4/2018, 200 consecutive patients who underwent radiofrequency ablation following a streamlined, fluoroless protocol developed at borgess medical center for paroxysmal or persistent atrial fibrillation were evaluated in this retrospective study".

• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8175726
• MDR Text Key: 130791340
• Report Number: 2029046-2018-02466
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/18/2018
• 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): Life Threatening
• Patient Age: 62 YR