MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

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

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

Related manufacturing ref: (b)(4).The following was published in journal of cardiovascular electrophysiology titled, "impact of a high-density grid catheter on long-term outcomes for structural heart disease ventricular tachycardia ablation", published,:04 january 2021, riccardo proietti md; et al.Substrate mapping has highlighted the importance of targeting diastolic conduction channels and late potentials during ventricular tachycardia (vt) ablation.State-of-the-art multipolar mapping catheters have enhanced mapping capabilities.The purpose of this study was to investigate whether long-term outcomes were improved with the use of a hd grid mapping catheter combining complementary mapping strategies in patients with structural heart disease vt.Two patients suffered pericardial effusions, one of which required a pericardial drain.One patient developed left bundle branch block necessitating device upgrade to biventricular pacing and one patient suffered pulmonary edema.Two patients that suffered femoral vascular complications, one with a groin hematoma, and one patient with a pseudoaneurysm - agilis.

Manufacturer Narrative

Concomitant device: tacticath¿ contact force ablation catheter, sensor enabled¿.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported pseudoaneurysm and hematoma remain unknown.

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13451270
• MDR Text Key: 285048022
• Report Number: 3008452825-2022-00042
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2022
• 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
• Patient Outcome(s): Other