MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ INTRODUCER, UNKNOWN

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A leak was noted at the hemostasis valve during functional testing.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.In addition, the sheath deflected in both directions when actuating the steering mechanism, and deflected in the correct shape with no resistance noted.The cause of the torn seals and subsequent leak is consistent with damage during use.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

Event Description

This report is to advise of an event observed during analysis confirming a hemostasis valve leak of the introducer.

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7482536
• MDR Text Key: 107197767
• Report Number: 2182269-2018-00065
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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