BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053
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Catalog Number UNK_SMART TOUCH BIDIRECTIONAL |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Type
Injury
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Event Description
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This complaint is from a literature source.The following literature cite has been reviewed: ding x, wang l, liu q, chen s, jiang r, yu l, zhang p, lin j, sun y, sheng x, fu g, zei pc, jiang c.Use of intracardiac echocardiography in vein of marshall ethanol infusion for ablation of persistent atrial fibrillation.Heart rhythm.2024 mar;21(3):274-281.Doi: 10.1016/j.Hrthm.2023.11.029.Epub 2023 dec 14.Pmid: 38103707.Objective/methods/study data: background: few methods have been reported to demonstrate real-time effects during vein of marshall (vom) ethanol infusion in persistent atrial fibrillation (peaf).Objective: this study was to evaluate the impact of left atrial (la) monitoring using intracardiac echocardiography (ice) during vom ethanol infusion.Methods: seventy-four consecutive patients with peaf who underwent vom ethanol infusion followed by radiofrequency (rf) ablation were included.Patients with findings on ice consistent with echogenic streaming in the la and with increased myocardial local echogenicity along the vom area were placed into one group (group a) and those without into the other group (group b).Outcomes between the 2 groups were compared.Results: forty-six patients (62%) were placed into group a.A new ethanol-induced low-voltage area in group a was larger than that in group b (8.5 cm2 [5.5-10.2 cm2] and 4.0 cm2 (2.4-6.3 cm2]; p <.001).The rf ablation time required to achieve mi block was reduced in group a patients (263.0 seconds [196.0-351.0 seconds] vs 417.0 seconds [315.0-709.5 seconds] in group b patients; p <.001).Mi block was achieved in 46 patients (100%) via an endocardial approach in group a and 27 patients (96.4%) in group b (extra coronary sinus ablation in 4 patients).One patient developed clinically significant pericardial effusions and required pericardiocentesis in group b.Conclusion: presence of increased myocardial local echogenicity at the ridge and consistent echogenic streaming in the la detected by ice-based imaging during vom ethanol infusion suggests increased ablated tissue in that region and lower rf ablation time during ablation for peaf.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter and 7-f decanav cs catheter concomitant biosense webster devices that were used in this study: pentaray mapping catheter, carto3 mapping system, 7-f decanav cs catheter concomitant non-biosense webster devices that were also used in this study: runthrough ns extra floppy guidewire (terumo), otw balloon (boston scientific), ht viewer mapping system (apt medical) adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 5 (pericardial effusion)(recognized procedural complication) qty 1 pericardial effusions and required pericardiocentesis (cardiac tamponade)(recognized procedural complication) adverse event(s) and provided interventions possibly associated with unidentified 7-f decanav cs catheter: qty 3 cs dissection during cs venography (vascular dissection)(recognized procedural complication).
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Manufacturer Narrative
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This complaint is from a literature source.The following literature cite has been reviewed: ding x, wang l, liu q, chen s, jiang r, yu l, zhang p, lin j, sun y, sheng x, fu g, zei pc, jiang c.Use of intracardiac echocardiography in vein of marshall ethanol infusion for ablation of persistent atrial fibrillation.Heart rhythm.2024 mar;21(3):274-281.Doi: 10.1016/j.Hrthm.2023.11.029.Epub 2023 dec 14.Pmid: 38103707.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00870 for a thermocool® smart touch¿ bi-directional navigation catheter (2) mfr # 2029046-2024-00871 for a decanav electrophysiology catheter.
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Manufacturer Narrative
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On 27-mar-2024, additional information was received from the author of the article indicating there was no relevance between the harm and the bwi product in the article.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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