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 Problem Fluid/Blood Leak (1250)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

During the procedure, a blood leak was noted from the hemostasis valve.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported leak could not be conclusively determined.

Event Description

During the atrial fibrillation procedure, a saline leak was noted from the hemostasis valve after the catheter was inserted.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

Additional information b5, g3.

Event Description

During the procedure, a saline leak was noted from the hemostasis valve.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15127194
• MDR Text Key: 304124788
• Report Number: 3008452825-2022-00532
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: 05414734206105
• 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,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 7134732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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