MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ventricular Fibrillation (2130)

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source: yunxian, zhao.Efficacy of radiofrequency ablation for tachycardia in patients with organic heart disease.No additional information was provided.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 no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Biosense webster manufacturer's reference number pc-001190266 has two complaints that are related to the same incident.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source: yunxian, zhao.Efficacy of radiofrequency ablation for tachycardia in patients with organic heart disease.No additional information was provided.Objective/methods/study data: the study tried to evaluate the efficacy of radiofrequency ablation for tachycardia in patients with organic heart disease.From october 2017 to april 2019, a total of 7 patients with ventricular tachycardia due to structural heart disease underwent radiofrequency ablation guided by carto, a cardiac three-dimensional mapping system, with good efficacy, effectively reducing the number of ventricular tachycardia attacks and improving the quality of life of patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: -johnson & johnson steerable thermocool smarttouch; this will be coded as unk_smart touch bidirectional for reportability purposes.Other biosense webster devices that were also used in this study: carto.Johnson & johnson ten grade deflectable sheath (johnson & johnson four grade fixed curve).Non-biosense webster devices that were also used in this study: indwell 7f arterial sheath (medtronic).8f arterial sheath (medtronic).Adverse event(s) and provided interventions.Two adverse events were reported in this article: one 52 year-old patient was converted to ventricular fibrillation by ecg monitoring.At the same time, the patient lost consciousness, had limb twitching and the blood pressure could not be measured.Therefore, the patient was given asynchronous bidirectional 200ws multiple electrical defibrillation to restore sinus rhythm.Another unknown patient had ventricular fibrillation during operation and recovered to sinus rhythm after asynchronous electrical defibrillation.No additional information was provided.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15375724
• MDR Text Key: 299450165
• Report Number: 2029046-2022-02144
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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: 08/16/2022
• 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: 8F ARTERIAL SHEATH (MEDTRONIC); INDWELL 7F ARTERIAL SHEATH (MEDTRONIC).; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening