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

Model Number	G402049
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an epicardial ventricular tachycardia procedure, an air leak was noted.The introducer was exchanged and the procedure was completed with no adverse consequences to the patient.Upon gaining epicardial access, the agilis introducer was inserted into the epicardial space and while attempting to flush, air was drawn back through the hemostatic valve and into the flush syringe.The sheath was replaced and successfully used for the procedure.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6.One 8.5f agilis steerable introducer sheath was received for evaluation.The dilator was also received.Functional testing confirmed an air leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent leak remains unknown.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER
• Common Device Name: 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: 16809686
• Report Number: 3008452825-2023-00171
• Device Sequence Number: 11512372
• Product Code: DYB
• UDI-Device Identifier: 05415067000255
• UDI-Public: 05415067000255
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K061363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: G402049
• Device Catalogue Number: G402049
• Device Lot Number: 8591863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 06/09/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/26/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown