MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 01/13/2020

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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report numbers: 2029046-2021-00602, 2029046-2021-00603, and 2029046-2021-00605 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 1 patient underwent catheter ablation of atrial fibrillation and suffered severe mucosal lesions.Intervention was not reported.(stsf).Model and catalog number are not available, but the suspected device is smart touch sf other biosense webster devices that were also used in this study: carto, lasso-nav, pentaray mapping catheter, non-biosense webster devices that were also used in this study: ensoetm probe, blanketrol iii, level 1vr oesophageal temperature probe.Publication details: title: randomized comparison of oesophageal protection with a temperature control device: results of the impact study.Objective: thermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (af).Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent.We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury.Methods: a single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoetm device to protect the oesophagus from thermal injury.This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe.In the protected group, the device maintained the luminal temperature at 4c during radiofrequency (rf) ablation for af under general anaesthesia.Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored.".

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: UNK
• 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: 11691415
• MDR Text Key: 247275100
• Report Number: 2029046-2021-00604
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 03/29/2021
• 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): Other
• Patient Age: 65 YR