MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F; INTRODUCER, CATHETER

Model Number G408319

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

During the procedure, the extension tube of the three way stopcock detached which resulted in blood leaking from the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The reported event of the sideport tubing becoming detached from the introducer, leading to a blood leak was confirmed.The sideport tubing had been detached from the hemostasis body.A leak was noted at this location due to the aforementioned damage.A leak was also 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.The cause of the torn seals and subsequent leak is consistent with damage during use.Further investigation revealed the sideport tubing was blocked by excessive adhesive proximal to the hemostasis hub, consistent with excess force required to flush the device and thus the reported sideport tubing detachment.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F
• Type of Device: 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
• MDR Report Key: 7642594
• MDR Text Key: 112505741
• Report Number: 3008452825-2018-00204
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206129
• UDI-Public: 05414734206129
• Combination Product (y/n): N
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: G408319
• Device Catalogue Number: G408319
• Device Lot Number: 6359102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other