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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Paralysis (1997); Paresis (1998); Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446); Pericarditis (4448)

Event Date 02/06/2023

Event Type  Injury  

Event Description

This complaint is from a literature source-the following literature cite has been reviewed- okamatsu h, okumura k, onishi f, yoshimura a, negishi k, tsurugi t, tanaka y, nakao k, sakamoto t, koyama j.Safety and efficacy of ablation index-guided atrial fibrillation ablation in octogenarians.Clin cardiol.2023 jul;46(7):794-800.Doi: 10.1002/clc.24031.Epub 2023 may 18.Pmid: 37199002; pmcid: pmc10352973.Objective/methods/study data:the study aimed to compare the efficacy and safety of ai-guided af ablation between af patients aged =80 years (group 1) and <80 (group 2).We aimed to compare the efficacy and safety of ai-guided af ablation between af patients aged =80 years (group 1) and <80 (group 2).: they retrospectively reviewed 2087 af patients undergoing their first ai- guided af ablation in our hospital.We compared the atrial tachyarrhythmia (at) recurrence and procedure-related complication rate between group 1 (n = 193) and group 2 (n = 1894).The mean age was 83.0 (interquartile range [iqr] 81.0, 84.0) years in group 1 and 67.0 (iqr 60.0, 72.0) in group 2.Af type was significantly different between the two groups: of group 1 patients, 120 (62.2%) had paroxysmal af, 61 (31.6%) persistent af, and 12 (6.2%) long-standing persistent af, while of group 2 patients, 1016 (53.6%) paroxysmal af, 582 (30.7%) persistent af, and 296 (15.6%) long- standing persistent af (p =.001).Unadjusted at recurrence-free survival curves showed similar at recurrence-free survival between the two groups (p =.67 by log- rank test).After the adjustment for af type, the survival curve was similar between them (hazard ratio, 1.24; 95% ci [0.92¿1.65]; p =.15, group 1 vs.Group 2).The rate of procedure-related complications was similar between the two groups (3.1% vs.3.0%, respectively, p =.83).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch surround flow; biosense webster).Other biosense webster devices that were also used in this study: 8fr soundstar ultrasound catheter (biosense webster), carto3 system, vizigo; johnson & johnson, guidee leftee; japan lifeline).Non-biosense webster devices that were also used in this study: 8.5 fr long sheaths (sl0; st jude medical) , 8.5 fr deflectable sheath (agilis; st jude medical), adverse event(s) and provided interventions qty 12 -cardiac tamponade ( 3 in group 1 and 9 in group 2).Qty 9 - phrenic nerve injury ( 1 in group 1 and 8 in group 2).Qty 9 - gastric hypomotility ( 1 in group 1 and 9 in group 2).Qty 2- stroke/thromboembolic events ( from group 2).Qty 9- heart failure ( from group 2).Qty 9 - pericarditis ( ( from group 2).Qty 4- nasal bleeding related to nasal airway device ( from group 2).

Manufacturer Narrative

This complaint is from a literature source-the following literature cite has been reviewed- okamatsu h, okumura k, onishi f, yoshimura a, negishi k, tsurugi t, tanaka y, nakao k, sakamoto t, koyama j.Safety and efficacy of ablation index-guided atrial fibrillation ablation in octogenarians.Clin cardiol.2023 jul;46(7):794-800.Doi: 10.1002/clc.24031.Epub 2023 may 18.Pmid: 37199002; pmcid: pmc10352973.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.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.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 1-sep-2023, the product investigation was completed as the complaint device was not returned.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.Manufacturer's reference number: (b)(4).

• 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: 17665091
• MDR Text Key: 322478090
• Report Number: 2029046-2023-01964
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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: 09/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 8.5 FR DEFLECTABLE SHEATH; 8.5 FR LONG SHEATHS (SL0, ST JUDE MEDICAL); 8FR SOUNDSTAR ULTRASOUND CATHETER; CARTO3 SYSTEM; GUIDEE LEFTEE; THERMOCOOL SMARTTOUCH SURROUND FLOW; VIZIGO
• Patient Outcome(s): Life Threatening