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

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

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

Related manufacturer ref: 3005334138-2021-00778, 3008452825-2021-00588.The following was published in bmc cardiovascular disorders, "minimising radiation exposure in catheter ablation of ventricular arrhythmias" by matev¿ jan et al: june 2021.A study was conducted to analyze procedural outcomes with fluoroscopy minimizing approach for treatment of ventricular arrhythmias in patients with structurally normal hearts (snh) and structural heart disease (shd) from (b)(6) 2018 through (b)(6) 2019.Procedures were preferably performed in conscious sedation, except for patients undergoing epicardial approach in whom general anesthesia was used.Femoral vein and artery punctures were performed to access the heart.A steerable long sheath (agilis¿, lrg curl introducer) was used to improve catheter stability in trans-septal approach.In addition, a uni-directional irrigated tip radio-frequency (rf) ablation catheter (flexibility¿ ablation catheter) was utilized in addition to non-abbott ablation catheters.All areas with late potentials and hidden slow conduction were extensively ablated using the described irrigated catheters with power-controlled settings of 30¿45 watts for at least 40 seconds or until the disappearance, or at least attenuation, of the local electrocardiogram.When epicardial mapping was needed a steerable long sheath (agilis epi¿ introducer) was inserted over the j-tip guide-wire through surgically prepared sub-xiphoid epicardial approach.One patient with an ischemic cardiomyopathy (icm) had a perforation of the right ventricle (rv) during an attempted surgical approach to the epicardium.The perforation was treated surgically.One patient had a late pericardial tamponade occurring one week after successful ablation of idiopathic right ventricular outflow tract (rvot) ectopy, which required percutaneous drainage.One patient with an icm had a pseudo-aneurysm of the left femoral artery that was treated surgically.(doi: https://doi.Org/10.1186/s12872-021-02120-4).

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported pseudoaneurysm could not be conclusively determined.

• Brand Name: AGILIS¿ INTRODUCER
• 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: 13062069
• MDR Text Key: 285229975
• Report Number: 3008452825-2021-00587
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• 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): Required Intervention