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

Model Number	G408321
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During aspiration of the sheath, a continuous stream of bubbles was noted.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One 8.5f agilis steerable introducer sheath was received for evaluation.Visual inspection revealed multiple bends throughout the sheath.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported 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: 17966670
• Report Number: 3008452825-2023-00478
• Device Sequence Number: 6790787
• Product Code: DYB
• UDI-Device Identifier: 05414734206143
• UDI-Public: 05414734206143
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: G408321
• Device Lot Number: 9042015
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown