MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F; INTRODUCER, CATHETER

Model Number 408310

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 10/12/2020

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 device preparation, the sheath was opened and placed on the sterile equipment table.When saline was flushed through the sheath, the liquid would not flush through the sheath.Then a new flush syringe was used to attempt to flush the sheath, but the issue persisted.The sheath was removed from the table and set aside while a replacement was opened and used instead.The sideport was also noted to have been detached outside of the patient.There was no patient consequences.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was returned for evaluation.The sideport tubing was no longer attached to the hemostasis body confirming the field reported event of the sideport detaching.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11142139
• MDR Text Key: 226060183
• Report Number: 3008452825-2020-00706
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: 05414734206105
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

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: 04/30/2023
• Device Model Number: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 7508166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 02/16/2021
• Supplement Dates FDA Received: 02/16/2021; 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2020
• 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