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 Problems Pleural Effusion (2010); Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 02/08/2023

Event Type  Injury  

Event Description

During an index procedure, the pacing lead dislodged when attempting transeptal puncture; the needle was inserted but not advanced during dislodgement.It is possible that the dilator caught and dislodged the lead.After the index procedure, lead revision was performed.

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, it is possible the dilator may have gotten caught and dislodged the lead.

Manufacturer Narrative

Additional information: b5, g3, h2, h3, h6 added health effect clinical code.

Event Description

The patient presented to emergency room on (b)(6) 2023 with shortness of breath and dyspnea on exertion.Patient had elevated ntprobnp and d-dimer.A chest cta was performed with results of large bilateral pleural effusions.Iv lasix was administered, and the patient was transferred to another hospital for admission and further management.

• 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: 16434643
• MDR Text Key: 310131085
• Report Number: 3008452825-2023-00073
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 8790860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 04/25/2023
• Supplement Dates FDA Received: 04/12/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 77 KG