MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134802

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Pseudoaneurysm (2605); Heart Failure/Congestive Heart Failure (4446); Pericarditis (4448)

Event Date 07/19/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: sasaki w, nakatani y, take y, kishi s, naito s.Transient left phrenic nerve paralysis after ethanol infusion into the vein of marshall.J cardiovasc electrophysiol.2022 jun 13.Doi: 10.1111/jce.15593.Epub ahead of print.Pmid: 35695797.Objective/methods/study data: this study aimed to compare the clinical outcomes of pulmonary vein isolation (pvi) alone and pwi in addition to pvi (pvi¿+¿pwi) in patients with non-paroxysmal atrial fibrillation (af) using a lesion size prediction module.This study is a sub-analysis of the recently published prospective multicentre observational study called alcoholaf (association of alcohol consumption with outcome of catheter ablation of af).In this sub-analysis, patients with non-paroxysmal af in whom pvi alone or pvi+pwi was performed using the lesion size prediction module were included.Freedom from atrial tachyarrhythmia was compared between pvi alone and pvi+pwi groups using propensity score analyses.Of the 3474 patients registered in the alcohol-af study, 572 patients (age 65.6+10.1 years, male 77.4%, longstanding persistent af 25.5%) were included in this sub-analysis.We selected 212 patients treated with pvi alone and 212 treated with pvi+pwi using one-to-one propensity score matching.During the follow-up period, atrial tachyarrhythmia recurrence was documented in 92 (43.4%) and 50 (23.6%) patients in the pvi alone and pvi+pwi groups, respectively.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: contact-force sensing catheter (thermocool smarttouch sf.Other biosense webster devices that were also used in this study: carto 3 , pentaray.Non-biosense webster devices that were also used in this study: ensite navx (abbott, st.Paul, mn), tacticath quartz, abbott medical), hd grid, abbott medical, adverse event(s) and provided interventions (associated with ablation in the cf group): qty 3 cardiac tamponade (pvi group) - no further information provided regarding interventions or outcome.Qty 1 pseudoaneurysm (pvi group) - no further information regarding specific injury/complication, interventions, or outcome.Qty 1 transient haemodynamic shock (pvi + pwi group) - no further information provided regarding interventions or outcome.Qty 1 aspiration pneumoniitis (pvi + pwi group) - no further information provided regarding interventions or outcome.Qty 1 bleeding at the site of vascular access (pvi + pwi group)- no further information provided regarding interventions or outcome.Qty 1 pericarditis (pvi + pwi group)- no further information provided regarding interventions or outcome.Qty 2 heart failure (pvi + pwi group) -no further information provided regarding interventions or outcome.Qty 2 sick sinus syndrome (pvi + pwi group) - no further information provided regarding interventions or outcome.

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: sasaki w, nakatani y, take y, kishi s, naito s.Transient left phrenic nerve paralysis after ethanol infusion into the vein of marshall.J cardiovasc electrophysiol.2022 jun 13.Doi: 10.1111/jce.15593.Epub ahead of print.Pmid: 35695797.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 not 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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• 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: 15317757
• MDR Text Key: 298873948
• Report Number: 2029046-2022-02040
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• 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
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134802
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• 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: CARTO 3; ENSITE NAVX (ABBOTT, ST. PAUL,); HD GRID, ABBOTT MEDICAL; PENTARAY; TACTICATH QUARTZ, ABBOTT MEDICAL
• Patient Outcome(s): Life Threatening