MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_NAVISTAR RMT THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 10/31/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: schlögl s, schlögl ks, haarmann h, bengel p, bergau l, rasenack e, hasenfuss g, zabel m.Remote magnetic navigation versus manual catheter ablation of atrial fibrillation: a single center long-term comparison.Pacing clin electrophysiol.2022 jan;45(1):14-22.Doi: 10.1111/pace.14392.Epub 2021 oct 31.Pmid: 34687054.Objective/methods/study data: background: data comparing remote magnetic catheter navigation (rmn) with manual catheter navigation (mcn) ablation of atrial fibrillation (af) is lacking.The aim of the present prospective observational study was to compare the outcome of rmn versus (vs.) mcn ablation of af with regards to af recurrence.Methods: the study comprised 667 consecutive patients with a total of 939 procedures: 287 patients were ablated using rmn, 380 using mcn.Results: there was no significant difference between the groups at baseline.After 2.3 2.3 years of follow-up, 23% of the patients in the mcn group remained free of af ± recurrence compared to 13% in the rmn group (p.001).After analysis of 299 repeat < ablations (133 mcn, 166 rmn) there was a significantly higher reconnection rate of pulmonary veins after rmn ablation p.001).In multivariable cox-regression analysis, rmn ablation was an independent risk factor for af recurrence besides age, persistent af, number of isolated pulmonary veins, and left atrial diameter.Procedure time, radiofrequency application time and total number of ablation points were higher in the rmn group.Conclusions: in the study the af recurrence rate and pulmonary vein reconnection rate is higher after rmn ablation with a similar complication rate but reduced probability of pericardial effusion when compared to mcn.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5 mm navistar thermocool rmt, biosense-webster, navistar thermocool, biosense webster, navistar thermocool sf, biosense webster.Other biosense webster concomitant devices that were also used in this study: lasso, biosense webster, diamond bar, ca, cartoxp or carto3 rmt, biosense webster, stockert, biosense webster.Non-biosense webster concomitant devices that were also used in this study: 6f steerable decapolar catheter; bard dynamic tip, bard inc., lowell, ma, usa, sl1 sheath (st.Jude medical, inc., st.Paul, mn, usa, agilis deflectable sheath; st jude medical.Adverse event(s) and provided interventions: there were 18 adverse events reported in this literature article: (8) pericardial effusion requiring pericardiocentesis.(2) cases of a post-procedural stroke, thereof one with a post-interventional ischemic stroke associated with heparin induced thrombocytopenia.(1) patient suffered a postprocedural sub segmental pulmonary embolism.(7) cases of blood transfusion was necessary after a peri-procedural bleeding.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: schlögl s, schlögl ks, haarmann h, bengel p, bergau l, rasenack e, hasenfuss g, zabel m.Remote magnetic navigation versus manual catheter ablation of atrial fibrillation: a single center long-term comparison.Pacing clin electrophysiol.2022 jan;45(1):14-22.Doi: 10.1111/pace.14392.Epub 2021 oct 31.Pmid: 34687054.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 4.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 ref #: (b)(4).

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14704540
• MDR Text Key: 294937105
• Report Number: 2029046-2022-01326
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR RMT THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/15/2022
• 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: 6F STEERABLE DECAPOLAR CATHETER, BARD INC.; AGILIS DEFLECTABLE SHEATH, ST JUDE MEDICAL; BARD DYNAMIC TIP, BARD INC.; CARTOXP OR CARTO3 RMT, BIOSENSE WEBSTER; LASSO, BIOSENSE WEBSTER, DIAMOND BAR, CA; SL1 SHEATH, ST. JUDE MEDICAL, INC.; STOCKERT, BIOSENSE WEBSTER
• Patient Outcome(s): Life Threatening; Required Intervention