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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Laceration(s) of Esophagus (2398); Pericarditis (4448)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

D4.Catalog: unk_smart touch bidirectional sf.This complaint is from a literature source.The following literature cite has been reviewed: valeriano c, buytaert d, fabbricatore d, de schouwer k, addeo l, de braekeleer l, geelen p, de potter t.High efficiency single-catheter workflow for radiofrequency atrial fibrillation ablation in the qdot catheter era.J interv card electrophysiol.2023 dec 14.Doi: 10.1007/s10840-023-01709-3.Epub ahead of print.Pmid: 38092999.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.Biosense webster manufacturer's reference number (b)(4) has two reports that are related to the same article: (1) mfr # for product code unk_smart touch bidirectional sf (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2024-00859 for product code unk_qdot micro (qdot micro).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: valeriano c, buytaert d, fabbricatore d, de schouwer k, addeo l, de braekeleer l, geelen p, de potter t.High efficiency single-catheter workflow for radiofrequency atrial fibrillation ablation in the qdot catheter era.J interv card electrophysiol.2023 dec 14.Doi: 10.1007/s10840-023-01709-3.Epub ahead of print.Pmid: 38092999.Objective/methods/study data: background: high-power short-duration (hpsd) ablation may improve the consistency and efficiency of pulmonary vein isolation (pvi).The novel qdot micro¿ catheter (biosense webster, inc.) with temperature feedback and microelectrodes aims to enhance pvi efficiency and safety.This study wants to evaluate the feasibility, safety, and efficiency of a standardized single-catheter workflow for pvi using qdot (q-flow).Methods: the q-flow includes single transeptal access, radiofrequency encircling of the pvs using a power of 50 w in a temperature/flow-controlled mode, and validation of the circles with microelectrodes.A 1:1 propensity-matched cohort of patients treated with conventional power-controlled ablation using a circular mapping catheter (cmc-flow) was used to compare procedural and clinical outcomes.Results: a total of 150 consecutive atrial fibrillation patients (paroxysmal 67%, persistent 33%) were included.First-pass isolation rate was 86%.Procedural time, x-ray time, and dose were significantly lower for the q-flow vs the cmc-flow (67.2 ± 17.9 vs 88.3 ± 19.2 min, p < 0.001; 3.0 ± 1.9 vs 5.0 ± 2.4 min, p < 0.001; 4.3 ± 1.9 vs 6.4 ± 2.3 gycm2, p < 0.001).Complications were numerically but not significantly lower in the q-flow group (2 [1.3%] vs 7 [4.7%], p = 0.091).There was no difference in arrhythmia recurrence at 12 months (atrial arrhythmia-free survival rate, 87.5% vs 84.4%, p = 0.565).Conclusion: a streamlined single-catheter workflow for pvi using qdot was feasible and safe, resulting in a high rate of first-pass isolation and a low complication rate.The q-flow further improved the efficiency of pvi compared to the standard cmc-flow, without difference in the 12-month outcome.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: qdot micro ablation catheter and thermocool smarttouch sf concomitant biosense webster devices that were used in this study: carto system.Lasso mapping catheter non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions possibly associated with unidentified qdot ablation catheter: qty 1 (pericarditis) (recognized procedural complication) qty 1 (cardiac tamponade) (recognized procedural complication) adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch sf ablation catheter: qty 1 (pericarditis) (recognized procedural complication) qty 4 (cardiac tamponade) (recognized procedural complication) qty 1 (esophageal ulcer) (recognized procedural complication).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18915113
• MDR Text Key: 337796167
• Report Number: 2029046-2024-00858
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• 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 SYSTEM; LASSO MAPPING CATHETER; UNK_QDOT MICRO
• Patient Outcome(s): Life Threatening