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	Pericardial Effusion (3271)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: zhang s, wu z, chen m, li x, liu q, zhou s.Comparison between conventional approach and three-dimensional mapping system in the catheter ablation of accessory pathway associated with coronary sinus diverticulum: a single-center experience.Ann noninvasive electrocardiol.2024 jan;29(1):e13100.Doi: 10.1111/anec.13100.Epub 2023 dec 20.Pmid: 38115789; pmcid: pmc10770808.Objective/methods/study data: background: posteroseptal accessory pathways (aps) associated with coronary sinus (cs) diverticulum present a rare and challenge for ablation.This study aimed to compare the safety and efficacy of conventional approach and three-dimensional (3d) mapping system in the catheter ablation.Methods and results: this was a retrospective study of all patients (from january 2013 to july 2022) who underwent catheter ablation of posteroseptal ap associated with cs diverticula in our center.Patients who underwent catheter ablation using the traditional fluoroscopy method were included in the conventional method group (n = 13).Patients who underwent catheter ablation using the 3d mapping method were included in the 3d mapping group (n = 11).Clinical characteristics, ablation procedure, and outcomes were recorded and analyzed between the two groups.Out of 669 patients with posteroseptal aps, 24 of them (3.6%) were associated with cs diverticula.All patients in both groups successfully completed the electrophysiological study.In the conventional method group, two patients experienced complications (one patient with pericardial effusion and the other patient with femoral arterial hematoma), and two patients had recurrence.However, no patients suffered from complications or recurrence during follow-up.The procedure time and fluoroscopy time in the conventional method group were significantly longer than those in the 3d mapping method group.Conclusions: the utilization of 3d mapping led to reduced fluoroscopy time, shorter procedure duration, enhanced acute success rates, and decreased incidence of complications.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 4mm tip ablation catheter assumed to be smarttouch.Biosense webster devices that were used in this study: n/a.Concomitant non-biosense webster devices that were also used in this study:transseptal needle (brk xs), swartz sheath (abbott), ht viewer mapping system (apt medical).The femoral arterial hematoma is associated with sheath usage (non biosense webster) in the study.Adverse event(s) and provided interventions possibly associated with smarttouch ablation catheter: qty 1 (pericardial effusion) (recognized procedural complication).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: zhang s, wu z, chen m, li x, liu q, zhou s.Comparison between conventional approach and three-dimensional mapping system in the catheter ablation of accessory pathway associated with coronary sinus diverticulum: a single-center experience.Ann noninvasive electrocardiol.2024 jan;29(1):e13100.Doi: 10.1111/anec.13100.Epub 2023 dec 20.Pmid: 38115789; pmcid: pmc10770808.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.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ bi-directional navigation catheter approved under pma # p030031/s053.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: 18927265
• Report Number: 2029046-2024-00898
• Device Sequence Number: 9446207
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/18/2024

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: Not provided
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: HT VIEWER MAPPING SYSTEM (APT MEDICAL).; SWARTZ SHEATH (ABBOTT).; TRANSSEPTAL NEEDLE (BRK XS).
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown