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 Thrombosis (2100)

Event Date 06/30/2016

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.Manufacturer's ref.No: (b)(4).

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was also reported that 1 patient underwent catheter ablation of atrial fibrillation and suffered thrombosis.Intervention not reported.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: carto3, smarttocuh thermocool sf.Non-biosense webster devices that were also used in this study: none.Publication details: title: the impact of steerable sheaths on unblinded contact force during catheter ablation for atrial fibrillation.Objective: the purpose of this study was to evaluate the impact of steerable sheaths on multiple contact force parameters during atrial fibrillation (af) ablation.Methods: this multi-center cohort study included consecutive patients (85) undergoing index pulmonary vein (pv) isolation with a force-sensing catheter between february 2014 and june 2016.Operators employed either only steerable or only fixed-curve sheaths.Operators targeted a force of 10¿40 g for each ablation lesion.Automated ablation lesion assessment software with standardized settings was employed.

• 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: 8774019
• MDR Text Key: 150543946
• Report Number: 2029046-2019-03401
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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: 06/18/2019
• 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): Other
• Patient Age: 58 YR