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

Catalog Number 408310

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Event Description

The pt was under anesthesia.An agilis sheath was inserted into the body.After several minutes in the body, physician attempted to flex the agilis sheath.The agilis sheath would not flex.It stayed in one position.Agilis sheath exchanged over the wire for a new agilis sheath.Second agilis sheath inserted into the body.No further issues.Pt still under anesthesia.At this time there is no visual appearance of harm to the patient.Agilis nxt steerable introducer med curl.

• Brand Name: AGILIS NXT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka, MN 55345
• MDR Report Key: 5856281
• MDR Text Key: 51495829
• Report Number: 5856281
• Device Sequence Number: 1
• Product Code: PNC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 408310
• Device Lot Number: 5482498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR