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 Paralysis (1997); Pericarditis (4448)

Event Date 01/16/2024

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: fitzpatrick n, herczeg s, hong k, seaver f, rosalejos l, boles u, jauvert g, keelan e, o'brien j, tahin t, galvin j, széplaki g.Long-term results of ablation index guided atrial fibrillation ablation: insights after 5+ years of follow-up from the mph af ablation registry.Front cardiovasc med.2024 jan 16;10:1332868.Doi: 10.3389/fcvm.2023.1332868.Pmid: 38292455; pmcid: pmc10825003.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 reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: fitzpatrick n, herczeg s, hong k, seaver f, rosalejos l, boles u, jauvert g, keelan e, o'brien j, tahin t, galvin j, széplaki g.Long-term results of ablation index guided atrial fibrillation ablation: insights after 5+ years of follow-up from the mph af ablation registry.Front cardiovasc med.2024 jan 16;10:1332868.Doi: 10.3389/fcvm.2023.1332868.Pmid: 38292455; pmcid: pmc10825003.Objective/methods/study data: background: catheter ablation (ca) for symptomatic atrial fibrillation (af) offers the best outcomes for patients.Despite the benefits of ca, a significant proportion of patients suffer a recurrence; hence, there is scope to potentially improve outcomes through technical innovations such as ablation index (ai) guidance during af ablation.We present real-world 5-year follow-up data of ai-guided pulmonary vein isolation.Methods: we retrospectively followed 123 consecutive patients who underwent ai-guided ca shortly after its introduction to routine practice.Data were collected from the mph af ablation registry with the approval of the institutional research board.Results: our patient cohort was older, with higher bmi, greater cha2ds2-vasc scores, and larger left atrial sizes compared to similar previously published cohorts, while gender balance and other characteristics were similar.The probability of freedom from atrial arrhythmia with repeat procedures is as follows: year 1: 0.95, year 2: 0.92, year 3: 0.85, year 4: 0.79, and year 5: 0.72.Age >75 years (p = 0.02, hr: 2.7, ci: 1.14-6.7), bmi >35 kg/m2 (p = 0.0009, hr: 4.6, ci: 1.8-11.4), and left atrial width as measured on ct in the upper quartile (p = 0.04, hr: 2.5, ci: 1-5.7) were statistically significant independent predictors of recurrent af.Conclusion: ai-guided ca is an effective treatment for af, with 95.8% of patients remaining free from atrial arrhythmia at 1 year and 72.3% at 5 years, allowing for repeat procedures.It is safe with a low major complication rate of 1.25%.Age >75 years, bmi >35 kg/m2, and markedly enlarged atria were associated with higher recurrence rates.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch surround flow df catheter.Biosense webster devices that were used in this study: carto 3 system, lasso mapping catheter, pentaray 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 smarttouch sf ablation catheter: qty 1 (pericarditis) requiring pericardiocentesis and steroid therapy (recognized procedural complication).Qty 1 right phrenic nerve injury (diaphragmatic paralysis) (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: 18913890
• MDR Text Key: 337779791
• Report Number: 2029046-2024-00851
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• 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 3 SYSTEM.; LASSO MAPPING CATHETER.; PENTARAY MAPPING CATHETER
• Patient Outcome(s): Required Intervention