Model Number D134801 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Stroke/CVA (1770); Pulmonary Edema (2020); Cardiac Tamponade (2226); Heart Block (4444); Pericarditis (4448)
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Event Date 08/01/2022 |
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: dhruva ss, zhang s, chen j, noseworthy pa, doshi aa, agboola km, herrin j, jiang g, yu y, cafri g, collison farr k, ervin kr, ross js, coplan pm, drozda jp jr.Safety and effectiveness of a catheter with contact force and 6-hole irrigation for ablation of persistent atrial fibrillation in routine clinical practice.Jama netw open.2022 aug 1;5(8):e2227134.Doi: 10.1001/jamanetworkopen.2022.27134.Pmid: 35976649; pmcid: pmc9386540.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: (2) mfr # 2029046-2023-01363 for product code unk_smart touch bidirectional.
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Event Description
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This complaint is from a literature source.The following literature cite has been reviewed: dhruva ss, zhang s, chen j, noseworthy pa, doshi aa, agboola km, herrin j, jiang g, yu y, cafri g, collison farr k, ervin kr, ross js, coplan pm, drozda jp jr.Safety and effectiveness of a catheter with contact force and 6-hole irrigation for ablation of persistent atrial fibrillation in routine clinical practice.Jama netw open.2022 aug 1;5(8):e2227134.Doi: 10.1001/jamanetworkopen.2022.27134.Pmid: 35976649; pmcid: pmc9386540.Objective/methods/study data:to use health system data to compare the safety and effectiveness of the cf-i6 catheter for persistent af ablation with the thermocool smarttouch surroundflow catheter (ablation catheter with contact force and 56-hole irrigation [cf-i56]), which is approved by the fda for this indication.This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent af at mercy health or mayo clinic from january 1, 2014, to april 30, 2021, with up to a 1-year follow-up using electronic health record data.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smartouch ablation catheter and thermocool smartouch sf ablation catheter.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: n/a.Exact quantities of products cannot be accurately determined as patients can experience more than adverse event and the data is summarized.Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional (cf-i6) : qty 1 acute stroke (cerebrovascular accident) (recognized procedural complication).Qty 23 (pericarditis) (recognized procedural complication).Qty 3 (pulmonary edema) (recognized procedural complication).Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional sf (cf-i56): qty 1 acute stroke (cerebrovascular accident) (recognized procedural complication).Qty 2 (heart block) (recognized procedural complication).Qty 16 (pericarditis) (recognized procedural complication).Qty 9 (pulmonary edema) (recognized procedural complication).Qty 2 (cardiac tamponade) (recognized procedural complication).
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Search Alerts/Recalls
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