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

Model Number	G408321
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the hemostatic portion of the sheath came apart.The introducer was removed normally and another introducer was used to complete the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
One agilis introducer was received for analysis.The blue hemostasis cap had been fractured and detached from the white hemostasis hub.Microscopic inspection revealed evidence of cap welding inside the hemostasis cap and hub; both the cap and hub material had been fractured.The condition of the dilator snap-lock was consistent with the dilator having been inserted and locked at the sheath hub.The hemostasis cap inside diameter was consistent with manufacturing specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported hemostasis cap detachment is consistent with damage during use.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8315242
• Report Number: 2182269-2019-00009
• Device Sequence Number: 10778756
• Product Code: DYB
• UDI-Device Identifier: 05414734206143
• UDI-Public: 05414734206143
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 11/29/2021
• Device Model Number: G408321
• Device Catalogue Number: G408321
• Device Lot Number: 6764551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1