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

Catalog Number	UNK_SMART TOUCH BIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: shinoda y, komatsu y, hattori m, oda y, iioka y, hanaki y, yamasaki h, igarashi m, ishizu t, nogami a.Optimal cardiac rhythm during substrate mapping in scar-related ventricular tachycardia: significance of wavefront direction on identifying critical sites.Heart rhythm.2024 mar 1:s1547-5271(24)00232-7.Doi: (b)(4).Epub ahead of print.Pmid: 38432425.Objective/methods/study data: background: a rotational activation pattern (rap) around the localized line of a conduction block often correlates with sites specific to the critical zones of ventricular tachycardia (vt).The wavefront direction during substrate mapping affects manifestation of the rap and line of block.Objective: the purpose of this study was to investigate the most optimal cardiac rhythm for identifying rap and line of block in substrate mapping.Methods: we retrospectively evaluated 71 maps (median 3205 points/map) in 46 patients (65 ± 15 years; 33% with ischemic cardiomyopathy) who underwent high-density substrate mapping and ablation of scar-related vt.Appearance of a rap during sinus, right ventricular (rv)-paced, left ventricular (lv)-paced, and biventricular-paced rhythms was investigated.Results: rap was identified in 24 of 71 maps (34%) in the region where wavefronts from a single direction reached but not in the region where wavefronts from multiple directions centripetally collided.The probability of identifying the rap depended on scar location; that is, anteroseptal and inferoseptal, inferior and apical, and basal lateral raps were likely to be identified during sinus/atrial, rv-paced, and lv-paced rhythms, respectively.In 13 patients, the rap was not evident in the baseline map but became apparent during remapping in the other rhythm, in which the wavefront reached the site earlier within the entire activation time.Conclusion: the optimal rhythm for substrate mapping depends on the spatial distribution of the area of interest.A paced rhythm with pacing sites near the scar may facilitate the identification of critical vt zones.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smart touch concomitant biosense webster devices that were used in this study: carto3 system, decanav, pentaray non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smart touch: qty 1: one patient did not undergo vt in­duction at the end of the procedure because of heart failure with impaired ejection fraction.(heart failure) (recognized procedural complication) (adverse event).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: shinoda y, komatsu y, hattori m, oda y, iioka y, hanaki y, yamasaki h, igarashi m, ishizu t, nogami a.Optimal cardiac rhythm during substrate mapping in scar-related ventricular tachycardia: significance of wavefront direction on identifying critical sites.Heart rhythm.2024 mar 1:s1547-5271(24)00232-7.Doi: (b)(4).Epub ahead of print.Pmid: 38432425.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 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.Manufacturer's ref #: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: 19625081
• Report Number: 2029046-2024-02117
• Device Sequence Number: 6520622
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_C3 CS REFSTAR - DEFLECTABLE; UNK_CARTO 3; UNK_PENTARAY
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown