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

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/23/2019

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: letsas kp, efremidis m, vlachos k, asvestas d, takigawa m, bazoukis g, frontera a, giannopoulos g, saplaouras a, sakellaropoulou a, mililis p, dragasis s, megarisiotou a, valkanas k, tse g, liu t, deftereos s, sideris a, baranchuk a, jais p.Right ventricular outflow tract low-voltage areas identify the site of origin of idiopathic ventricular arrhythmias: a high-density mapping study.J cardiovasc electrophysiol.2019 nov;30(11):2362-2369.Doi: 10.1111/jce.14155.Epub 2019 sep 22.Pmid: 31502366.Objective/methods/study data: this study investigated whether high-density endocardial bipolar voltage mapping of the right ventricular outflow tract (rvot) during sinus rhythm may guide catheter ablation of idiopathic ventricular arrhythmias (vas).Forty-four patients (18 males, mean age: 38.1 ± 13.8 years)with idiopathic rvot vas and negative cardiac magnetic resonance imaging underwent a stepwise mapping approach for the identification of the site of origin (soo).High-density electronatomical mapping (1096.6 ± 322.3 points) was performed during sinus rhythm and identified at least two low bipolar voltage areas less than 1mv (mean amplitude of 0.20 ± 0.10 mv) in 39 of 44 patients.The mean low voltage surface area was 1.4 ± 0.8 cm2.Group 1 consisted of 28 patients exhibiting low-voltage areas and high-arrhythmia burden during the procedure.Pace match to the clinical vas was produced in one of these low-voltage areas.Activation mapping during the procedure.Pace mapping produced a near-perfect or perfect match to the clinical vas in one of these areas in 9 of 11 patients which was marked as potential soo and targeted for ablation.During the follow-up period, 25 of 28 patients from group 1 (89%) and 7 of 9 patients from group 2 (78%) were free from vas.Established the soo at these sites in 27 of 28 cases.Group 2 comprised 11 patients exhibiting abnormal electroanatomical mapping, but very low-arrhythmia burden during the procedure.Pace mapping produced a near-perfect or perfect match to the clinical vas in one of these areas in 9 of 11 patients which was marked as potential soo and targeted for ablation.During the follow-up period, 25 of 28 patients from group 1 (89%) and 7 of 9 patients from group 2 (78%) were free from vas.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch catheter other biosense webster devices that were also used in this study: carto 3 , (decanav catheter 7f), non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: qty 1 ventricular fibrillation required cardioversion.

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: letsas kp, efremidis m, vlachos k, asvestas d, takigawa m, bazoukis g, frontera a, giannopoulos g, saplaouras a, sakellaropoulou a, mililis p, dragasis s, megarisiotou a, valkanas k, tse g, liu t, deftereos s, sideris a, baranchuk a, jais p.Right ventricular outflow tract low-voltage areas identify the site of origin of idiopathic ventricular arrhythmias: a high-density mapping study.J cardiovasc electrophysiol.2019 nov;30(11):2362-2369.Doi: 10.1111/jce.14155.Epub 2019 sep 22.Pmid: 31502366.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 reference number: (b)(4).

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15482055
• MDR Text Key: 300583263
• Report Number: 2029046-2022-02317
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3; DECANAV CATHETER 7F
• Patient Outcome(s): Life Threatening; Required Intervention