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 Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

Manufacturer ref# 3008452825-2022-00432.During persistent atrial fibrillation procedure, after inserting the sheath set into a patient prior to inserting catheters and a transseptal needle, the air was aspirated into a syringe that connected to the extension port of the sheath.The sheath set was replaced, but the air was aspirated into a syringe that connected to the extension port of the sheath.The second sheath was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was received for evaluation.The reported event of an air leak could not be confirmed.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• 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
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14490685
• MDR Text Key: 292805213
• Report Number: 3008452825-2022-00433
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206129
• UDI-Public: 05414734206129
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G408319
• Device Catalogue Number: G408319
• Device Lot Number: 8017328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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
• Treatment: AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 8.5F