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
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: schlögl s, schlögl ks, bengel p, haarmann h, bergau l, rasenack e, hasenfuss g, zabel m.Contact force sensing manual catheter versus remote magnetic navigation ablation of atrial fibrillation: a single-center comparison.Heart vessels.2024 jan 8.Doi: 10.1007/s00380-023-02344-8.Epub ahead of print.Pmid: 38189924.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 ref # (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: schlögl s, schlögl ks, bengel p, haarmann h, bergau l, rasenack e, hasenfuss g, zabel m.Contact force sensing manual catheter versus remote magnetic navigation ablation of atrial fibrillation: a single-center comparison.Heart vessels.2024 jan 8.Doi: 10.1007/s00380-023-02344-8.Epub ahead of print.Pmid: 38189924.Objective/methods/study data: background: data comparing remote magnetic catheter navigation (rmn) with manual catheter navigation in combination with contact force sensing (mcn-cf) ablation of atrial fibrillation (af) is lacking.The primary aim of the present retrospective comparative study was to compare the outcome of rmn versus (vs.) mcn-cf ablation of af with regards to af recurrence.Secondary aim was to analyze periprocedural risk, ablation characteristics and repeat procedures.Methods: retrospectively analyzed 452 patients undergoing a total of 605 ablations of af: 180 patients were ablated using rmn, 272 using mcn-cf.Results: except body mass index there was no significant difference between groups at baseline.After a mean 1.6 ± 1.6 years of follow-up and 1.3 ± 0.4 procedures, 81% of the patients in the mcn-cf group remained free of af recurrence compared to 53% in the rmn group (p < 0.001).After analysis of 153 repeat ablations (83 mcn-rf vs.70 rmn; p = 0.18), there was a significantly higher reconnection rate of pulmonary veins after rmn ablation (p < 0.001).In multivariable cox-regression analysis, rmn ablation (p < 0.001) and left atrial diameter (p = 0.013) was an independent risk factor for af recurrence.Procedure time, radiofrequency application time and total fluoroscopy time and fluoroscopy dose were higher in the rmn group without difference in total number of ablation points.Complication rates did not differ significantly between groups (p = 0.722).Conclusions: in retrospective comparative study, the af recurrence rate and pulmonary vein reconnection rate is significantly lower with more favorable procedural characteristics and similar complication rate utilizing mcn-cf compared to rmn.Table 3 note: the post procedural groin complications are associated with sheaths and the article identifies non-biosense webster sheaths used in the study.Pericardiocentesis after failed transseptal puncture are associated with transseptal sheath and needle that are not identified in the article.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar thermocool rmt in the rmn group, thermocool smarttouch sf in mcn-cf group.Concomitant biosense webster devices that were used in this study: lasso mapping catheter, carto mapping system, smartablate generator concomitant non-biosense webster devices that were also used in this study: transseptal sl1 sheath (st.Jude) in rmn group, agilis sheath (st.Jude) in mcn-cf group, niobe ii (steriotaxis) magnetic navigation system in rmn group.Adverse event(s) and provided interventions possibly associated with unidentified navistar thermocool rmt ablation catheter in the rmn group in table 3: qty 2 postprocedural effusion after ablation (pericardial effusion) (recognized procedural complication).Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch sf ablation catheter in the mcn-cf group in table 3: qty 1 postprocedural effusion after ablation (pericardial effusion) (recognized procedural complication).Qty 2 phrenic nerve palsy (diaphragmatic paralysis) (recognized procedural complication).

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18938438
• Report Number: 2029046-2024-00937
• Device Sequence Number: 15214443
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_NAVISTAR RMT THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS SHEATH (ST. JUDE) IN MCN-CF; CARTO MAPPING SYSTEM; LASSO MAPPING CATHETER; NIOBE II (STERIOTAXIS) MAGNETIC NAVIGATION SYSTEM; SMARTABLATE GENERATOR; TRANSSEPTAL SL1 SHEATH (ST. JUDE)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown