MAUDE Adverse Event Report: ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM, AGILIS¿ NXT STEERABLE INTRODUCER, 40CM SMALL CURL DU; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	G402047
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a vein of marshall alcohol ablation procedure, an air leak occurred.The introducer was in the endocardial space.Access was obtained through the internal jugular (ij) and the introducer was being used to gain access to the coronary sinus (cs) ostium from above.While in the heart, the physician was "pulling back" air only (not blood) through the sheath.It was confirmed that the device was in the heart, not the lungs.The physician felt that the hemostasis valve was compromised, and the air was being pulled through the valve.Upon removing the introducer from the patient, the physician had trouble re-inserting the dilator into the sheath.The device was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 8.5f agilis steerable introducer sheath and dilator were received for evaluation.Functional testing confirmed an air leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals, consistent with the reported and observed air leak.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seals and subsequent air leak remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• Brand Name: EPICARDIAL CATHETER SYSTEM, AGILIS¿ NXT STEERABLE INTRODUCER, 40CM SMALL CURL DU
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19616314
• Report Number: 3008452825-2024-00349
• Device Sequence Number: 6197606
• Product Code: DRF
• UDI-Device Identifier: 05414734216418
• UDI-Public: (01)05414734216418(10)10280999(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: G402047
• Device Catalogue Number: G402047
• Device Lot Number: 10280999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male