| Catalog Number UNK_SMART TOUCH BIDIRECTIONAL |
| Device Problem
Patient Device Interaction Problem (4001)
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| Patient Problems
Air Embolism (1697); Stroke/CVA (1770); Cardiac Tamponade (2226); Laceration(s) of Esophagus (2398); Ischemic Heart Disease (2493)
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| Event Date 11/19/2023 |
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Event Type
Injury
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Manufacturer Narrative
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This complaint is from a literature source.The following literature cite has been reviewed: müller j, nentwich k, berkovitz a, sonne k, kozlova o, barth s, deacanu a, waechter c, halbfass p, lehrmann h, deneke t.Recurrent atrial fibrillation ablation after initial successful pulmonary vein isolation.J clin med.2023 nov 19;12(22):7177.Doi: 10.3390/jcm12227177.Pmid: 38002789; pmcid: pmc10672075.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 the lot number was not 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).
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Event Description
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This complaint is from a literature source.The following literature cite has been reviewed: müller j, nentwich k, berkovitz a, sonne k, kozlova o, barth s, deacanu a, waechter c, halbfass p, lehrmann h, deneke t.Recurrent atrial fibrillation ablation after initial successful pulmonary vein isolation.J clin med.2023 nov 19;12(22):7177.Doi: 10.3390/jcm12227177.Pmid: 38002789; pmcid: pmc10672075.Objective/methods/study data: background: pulmonary vein isolation (pvi) is an effective treatment option for patients with symptomatic atrial fibrillation (af).However, the electrical recovery of pulmonary veins (pvs) is the main trigger for af recurrences.This study investigates the characteristics of patients admitted for redo af ablation, the pv reconnection rates depending on previous ablation modalities and the impact of different ablation strategies for redo procedures.Methods: consecutive patients undergoing first redo af ablation were included.Patients were grouped according to the electrical recovery of at least one pv.The impacts of the technique for first af ablation on pv reconnection rates and patients with and without pv reconnection were compared.Different ablation strategies for redo procedures were compared and its recurrence rates after a mean follow-up of 25 ± 20 months were investigated.Results: a total of 389 patients (68 ± 10 years; 57% male; 39% paroxysmal af) underwent a first redo.The median time between the first and redo procedure was 40 ± 39 months.Radiofrequency was used in 278 patients, cryoballoon was used in 85 patients and surgical af ablation was performed on 26 patients.In total, 325 patients (84%) had at least one pv reconnected, and the mean number of reconnected pvs was 2.0 ± 1.3, with significant differences between ablation approaches (p for all = 0.002); this was mainly due to differences in the left inferior pv and right superior pv reconnections.The presence of pv reconnection during redo was not associated with better long-term success compared to completely isolated pvs (67% vs.67%; log-rank p = 0.997).Overall, the different ablation strategies for redos were comparable regarding af recurrences during follow-up (p = 0.079), with the ablation approach having no impact in the case of left atrial low voltage or without.Conclusions: pv reconnections after initial successful pvi are common among all techniques of af ablation.Long-term rhythm control off antiarrhythmic drugs was possible in 2/3 of all patients after the redo procedure; however, different ablation strategies with extra-pv trigger ablation did not improve long-term success.Patients with recurrent af after pvi constitute a challenging group of patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf concomitant biosense webster devices that were used in this study: carto 3, lasso mapping catheter, smartablate generator.Non-biosense webster devices that were also used in this study: n/a.No device malfunctions reported.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch sf ablation catheter: qty 1 (cardiac tamponade) (recognized procedural complication).Qty 2 strokes (cerebrovascular accident) (recognized procedural complication).Qty 2 transient st segment elevations(st segment elevation) (minor injury).Qty 2 (air embolisms) noted under major complications (serious injury).Qty 6 endoscopically detected esophageal lesions (esophageal ulcer) (minor injury) - no interventions reported.
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Search Alerts/Recalls
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