MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number	UNK_SMART TOUCH BIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Heart Block (4444); Pericarditis (4448)
Date of Event	12/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source-the following literature cite has been reviewed- de potter t, sarkozy a, duytschaever m, bulava a.Safety and efficacy of catheter ablation on patients with persistent atrial fibrillation by targeting repetitive activation patterns and focal impulses.Pacing clin electrophysiol.2023 jul;46(7):729-737.Doi: 10.1111/pace.14708.Epub 2023 may 20.Pmid: 37208935.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).
Event or Problem Description
This complaint is from a literature source-the following literature cite has been reviewed- de potter t, sarkozy a, duytschaever m, bulava a.Safety and efficacy of catheter ablation on patients with persistent atrial fibrillation by targeting repetitive activation patterns and focal impulses.Pacing clin electrophysiol.2023 jul;46(7):729-737.Doi: 10.1111/pace.14708.Epub 2023 may 20.Pmid: 37208935.Objective/methods/study data:the study is intended to evaluate the acute and long-term effectiveness and peri-procedural safety in ablation of persistent atrial fibrillation (psaf) using the cartofinder algorithm guided ablation (cfga) targeting on repetitive activation patterns (raps) and focal impulses (fis) identified in dynamic maps.Sixty-four psaf patients (age, 60.7 ± 9.1 years; male, 76.6%; median psaf duration, 6.0 months) underwent cfga on raps/fis.Six patients (9.4%) reported primary adverse event (pae) including groin hematoma (2), complete heart block (1), tamponade (1), pericarditis (1), and pseudoaneurysm (1).Repeated mapping and ablation on raps/fis resulted in the cycle length (cl) increase from 191.0 ± 167.6 ms at baseline to 365.7 ± 296.7 ms in the la and from 167.8 ± 41.6 ms to 379.4 ± 293.5 ms in the ra and 30.2% (19/63) af termination to sr or organized at.The 12-month arrhythmia-free and symptomatic af-free rates were 60.9% and 75.0%, respectively.Patients with acute af termination showed a higher 12-month arrhythmia-free rate (76.9%) than those without (50.0%, p =.04).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: (thermocool smarttouch tm catheter [st], biosense webster, irvine, ca.Other biosense webster devices that were also used in this study: cartofindertm, biosense webster,irvine, ca) , non-biosense webster devices that were also used in this study: multielectrode basket-shaped mapping catheter (constellationtm, boston scientific).Adverse event(s) and provided interventions qty 1 -cardiac tamponade, epicardial drainage leading to recovery.Qty 1 - complete atrioventricular conduction block requiring implantation of pacemaker.Qty 1- pericarditist, fully recovered in 5 days.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 17645544
• Report Number: 2029046-2023-01917
• Device Sequence Number: 7556225
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/29/2023

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: 08/03/2023
• Initial Report FDA Received Date: 08/29/2023
• 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: CARTOFINDERTM BWI.; MULTIELEC BASKETSHAPED MAPCATH(CONSTTM BOSTON SC.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown