MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 12/13/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed:kim my, coyle c, tomlinson dr, sikkel mb, sohaib a, luther v, leong km, malcolme-lawes l, low b, sandler b, lim e, todd m, fudge m, wright ij, koa-wing m, ng fs, qureshi na, whinnett zi, peters ns, newcomb d, wood c, dhillon g, hunter rj, lim pb, linton nwf, kanagaratnam p.Ectopy-triggering ganglionated plexuses ablation to prevent atrial fibrillation: ganglia-af study.Heart rhythm.2022 apr;19(4):516-524.Doi: 10.1016/j.Hrthm.2021.12.010.Epub 2021 dec 13.Pmid: 34915187; pmcid: pmc8976158.Objective/methods/study data: background: the ganglionated plexuses (gps) of the intrinsic cardiac autonomic system may play a role in atrial fibrillation (af).Objective: we hypothesized that ablating the ectopy-triggering gps (et-gps) prevents af.Methods: ganglia-af was a prospective, randomized, controlled, 3-center trial.Et-gps were mapped using high frequency stimulation, delivered within the atrial refractory period and ablated until nonfunctional.If triggered af became incessant, atrioventricular dissociating gps were ablated.We compared gp ablation (gpa) without pulmonary vein isolation (pvi) against pvi in patients with paroxysmal af.Follow-up was for 12 months including 3-monthly 48-hour holter monitors.The primary end point was documented 30 seconds of atrial arrhythmia after a 3-month blanking period.Results a total of 102 randomized patients were analyzed on a per-protocol basis after gpa (n 5 52; 51%) or pvi (n 5 50; 49%).Patients who underwent gpa had 89 6 26 high frequency stimulation sites tested, identifying a median of 18.5% (interquartile range 16%¿21%) of gps.The radiofrequency ablation time was 22.9 6 9.8 minutes in gpa and 38 6 14.4 minutes in pvi (p,.0001).The freedom from 30 seconds of atrial arrhythmia at 12-month follow-up was 50% (26 of 52) with gpa vs 64% (32 of 50) with pvi (log-rank, p 5.09).Et-gpa without atrioventricular dissociating gpa achieved 58% (22 of 38) freedom from the primary end point.There was a significantly higher reduction in antiarrhythmic drug usage post ablation after gpa than after pvi (55.5% vs 36%; p 5.05).Patients were referred for redo ablation procedures in 31% (16 of 52) after gpa and 24% (12 of 50) after pvi (p 5.53).Conclusion gpa did not prevent atrial arrhythmias more than pvi.However, less radiofrequency ablation was delivered to achieve a higher reduction in antiarrhythmic drug usage with gpa than with pvi.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch, biosense webster.Other biosense webster concomitant devices that were also used in this study: lassonav, biosense webster, diamond bar, ca.Carto, biosense webster.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: there were a total of nine adverse events reported in this literature article: 1 patient suffered cardiac tamponade, which resolved with pericardiocentesis.The patient was discharged the following day.8 patients were hospitalized with symptoms consistent with pericarditis.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed:kim my, coyle c, tomlinson dr, sikkel mb, sohaib a, luther v, leong km, malcolme-lawes l, low b, sandler b, lim e, todd m, fudge m, wright ij, koa-wing m, ng fs, qureshi na, whinnett zi, peters ns, newcomb d, wood c, dhillon g, hunter rj, lim pb, linton nwf, kanagaratnam p.Ectopy-triggering ganglionated plexuses ablation to prevent atrial fibrillation: ganglia-af study.Heart rhythm.2022 apr;19(4):516-524.Doi: 10.1016/j.Hrthm.2021.12.010.Epub 2021 dec 13.Pmid: 34915187; pmcid: pmc8976158.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.Manufacturer's ref #: pc-(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 14700735
• MDR Text Key: 294942093
• Report Number: 2029046-2022-01323
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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_SMART TOUCH BIDIRECTIONAL
• 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: CARTO, BIOSENSE WEBSTER; LASSONAV, BIOSENSE WEBSTER,
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization