MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS NXT STEERABLE INTR. 8.5F, SMALL CURL, 71CM; INTRODUCER, CATHETER

Model Number G408320

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

During a pulmonary vein isolation procedure, the dilatator punctured the sheath.The stylet had been used and no additional puncture site was necessary.The sheath was swapped out and the procedure was successfully completed with no patient consequences.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was received for evaluation.No visual anomalies were noted on the returned sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported damage remains unknown.

• Brand Name: AGILIS NXT STEERABLE INTR. 8.5F, SMALL CURL, 71CM
• 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: 17067171
• MDR Text Key: 317153023
• Report Number: 3008452825-2023-00230
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206136
• UDI-Public: 05414734206136
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G408320
• Device Catalogue Number: G408320
• Device Lot Number: 8523763
• 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: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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