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

Model Number G408318

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, a blood leak was noted from the handle part of the introducer.The procedure was completed without replacing the device and there were no adverse consequences to the patient.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was received for evaluation.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 seal.There was no evidence of a leak within the handle.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal 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.

• Brand Name: AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 61 CM SHEATH, SMALL CURL DUAL-REACH
• 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 MN 1897- 4050; CS 1897-4050
• MDR Report Key: 11056997
• MDR Text Key: 223182922
• Report Number: 3005334138-2020-00644
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206112
• UDI-Public: 05414734206112
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: G408318
• Device Catalogue Number: G408318
• Device Lot Number: 7635230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1