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 Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2024

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, the guidewire became entangled with intervention required.The first puncture was done with a needle and guidewire from the agilis sheath.The wire was inserted, did not progress and after manipulation was unable to be removed.Fluoroscopy revealed the wire was entangled with something and when attempting to remove it, the wire stretched and unraveled.A vascular interventionist was called to remove the wire with no consequences.The procedure was stopped to avoid administering heparin to the patient.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath, dilator and guidewire assembly were received for evaluation.The returned guidewire was noted to be stuck within a non-abbott introducer.The guidewire was noted to be damaged.The outer coil of the guidewire was noted to be unraveled and stretched at its distal end.No damage was noted to the inner coil.Both the dilator distal tip inside diameter and the returned guidewire outside diameter measurements were within specifications.No resistance or other functional anomalies were noted when a stock guidewire from current abbott inventory was inserted through the dilator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire entanglement remains unknown.The cause of the guidewire damage is consistent with damage during use.

• 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: 19106072
• MDR Text Key: 340716382
• Report Number: 3008452825-2024-00213
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: (01)05414734206105(10)10039869(17)260930
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 408310
• Device Lot Number: 10039869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2023
• 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
• Patient Outcome(s): Required Intervention