MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pneumothorax (2012); Heart Block (4444)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature citation has been reviewed: tao, h.The effectiveness of the domestic three-dimensional measuring system in treating paroxysmal ventricular velocity, evaluation of safety and cost of surgery.Clinical journal of practical hospitals may 2021 volume 18 issue 3,article number 1672-6170 (2021) 03-0078-03.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.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 literature citation has been reviewed: tao, h.The effectiveness of the domestic three-dimensional measuring system in treating paroxysmal ventricular velocity, evaluation of safety and cost of surgery.Clinical journal of practical hospitals may 2021 volume 18 issue 3,article number 1672-6170 (2021) 03-0078-03.Objective/methods/study data: the authors tried to explore the application value of domestic three-dimensional marking system for the treatment of paroxysmal supraventricular tachycardia.300 patients with paroxysmal supraventricular tachycardia rf ablation, divided into traditional two-dimensional groups, imported three-dimensional groups and domestic three-dimensional groups each of 100 cases according to the surgical method, respectively, using x-ray, imported three-dimensional standard system and domestic three-dimensional standard system to conduct rf ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: johnson & johnson rf ablation instrument; coded as unk_ smarttouch bidirectional sf other biosense webster devices that were also used in this study: carto 3.Non-biosense webster devices that were also used in this study: bade company electrophysiology (lab system).Sichuan jinjiang electronics 3ding three-dimensional electroanatomical measurement system surgery.Adverse event(s) and provided interventions (associated with ablation in the cf group): qty 2 pneumothorax (1 from the traditional two-dimensional group and 1 from imported three-dimensional group )- no further information provided regarding interventions or outcome.Qty 1 first degree av block ( from imported three-dimensional group)- no further information provided regarding interventions or outcome.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16001942
• MDR Text Key: 305686305
• Report Number: 2029046-2022-03165
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2022

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: 11/21/2022
• Initial Date FDA Received: 12/19/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: BADE COMPANY ELECTROPHYSIOLOGY (LABSYSTEM); CARTO 3; SICHUAN JINJIANG ELECTRONICS 3DING
• Patient Outcome(s): Other