MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hematoma (1884); Cardiogenic Shock (2262)

Event Date 12/31/2018

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).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.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report numbers: 2029046-2019-04034, 2029046-2019-04035, 2029046-2019-04036, 2029046-2019-04039, 2029046-2019-04040, 2029046-2019-04043 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled,¿ targeted ablation of ventricular tachycardia guided by wavefront discontinuities during sinus rhythm (pmid:(b)(4)).1 patient, with a large chronic anterior infarction with apical aneurysm and ef of 10% who underwent ablation with hemodynamic support (intra-aortic balloon pump and impella) because of vt storm in the setting of ongoing cardiogenic shock died.He suffered a large femoral hematoma from venous bleeding on the first operative day in the intensive care unit requiring 4 units packed red blood cell transfusion and albumin.Systemic anticoagulation was withheld, and the patient suffered multiple embolic strokes and care was withdrawn subsequently.The aim of this study prospectively assessed outcomes of vt ablation guided primarily by the targeting of deceleration zones (dz) identified by propagational analysis of ventricular activation during sinus rhythm.Methods: one hundred twenty patients (median age 65 years underwent 144 ablation procedures for scar-related vt.57% of patients had previous ablation and epicardial access was employed in 59% of cases patients with scar-related vt were prospectively enrolled in the university of chicago vt ablation registry between 2016 and 2018.Isochronal late activation maps annotated to the latest local electrogram deflection were created with high-density multielectrode mapping catheters.Targeted ablation of dz (>3 isochrones within 1cm radius) was performed, prioritizing later activated regions with maximal isochronal crowding.When possible, activation mapping of vt was performed, and successful ablation sites were compared with dz locations for mechanistic correlation.Patients were prospectively followed for vt recurrence and mortality.

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9500878
• MDR Text Key: 172185746
• Report Number: 2029046-2019-04032
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 12/02/2019
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: FLEXABILITY SE CARDIAC ABLATION CATHETER
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 65 YR