MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226); Vascular Dissection (3160); Renal Impairment (4499)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: anter e, neuzil p, reddy vy, petru j, park km, sroubek j, leshem e, zimetbaum pj, buxton ae, kleber ag, shen c, wit al.Ablation of reentry-vulnerable zones determined by left ventricular activation from multiple directions: a novel approach for ventricular tachycardia ablation: a multicenter study (physio-vt).Circ arrhythm electrophysiol.2020 jun;13(6):e008625.Doi: 10.1161/circep.120.008625.Epub 2020 may 6.Pmid: 32372657; pmcid: pmc7321829.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.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 Description

This complaint is from a literature source.The following literature cite has been reviewed: anter e, neuzil p, reddy vy, petru j, park km, sroubek j, leshem e, zimetbaum pj, buxton ae, kleber ag, shen c, wit al.Ablation of reentry-vulnerable zones determined by left ventricular activation from multiple directions: a novel approach for ventricular tachycardia ablation: a multicenter study (physio-vt).Circ arrhythm electrophysiol.2020 jun;13(6):e008625.Doi: 10.1161/circep.120.008625.Epub 2020 may 6.Pmid: 32372657; pmcid: pmc7321829.Objective/methods/study data:the optimal method to identify the arrhythmogenic substrate of scar-related ventricular tachycardia (vt) is unknown.Sites of activation slowing during sinus rhythm (sr) often colocalize with the vt circuit.However, the utility and limitations of such approach for guiding ablation are unknown.We conducted a multicenter study in patients with infarct-related vt.The left ventricular (lv) was mapped during activation from 3 directions: sr (or atrial pacing), right ventricular, and lv pacing at 600 ms.Ablation was applied selectively= to the cumulative area of slow activation, defined as the sum of all regions with activation times of 40 ms per 10 mm.Hemodynamically tolerated vts were mapped with activation or entrainment.The primary outcome was a composite of appropriate implanted cardioverter-defibrillator therapies and cardiovascular death.The area of maximal activation slowing often corresponded to the site where the wavefront first interacted with the infarct.During a follow-up period of 3.6 years, the primary end point occurred in 14 out of 85 (16.5%) patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool surround-flow or thermocool smart-touch surround-flow catheters other biosense webster devices that were also used in this study: carto3 with pentaray (electrode spacing 2-6-2; biosense webster, (b)(4)) in 7.2% of patients.Non-biosense webster devices that were also used in this study: rhythmia with its orion basket catheter (boston scientific, (b)(4)).Adverse event(s) and provided interventions:qty:6 one patient developed pericardial effusion with tamponade that required percutaneous drainage, 1 patient had stroke with residual mild left hemiparesis, and 3 patients had vascular injury that required intervention.In addition, 1 patient developed transient acute or chronic renal failure.Article does report deaths in follow up data but does not report deaths are related to use of the devices within the study.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13497542
• MDR Text Key: 289950133
• Report Number: 2029046-2022-00253
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening