MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) AVEIR¿ INTRODUCER KIT ¿ 50 CM; Introducer, catheter

Model Number	LSN25501
Medical Device Problem Codes	Fluid/Blood Leak (1250); Product Quality Problem (1506)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for initial implant procedure on (b)(6) 2026.During procedure, it was found that the introducer exhibited no backflow when being flushed and exhibited signs of air leakage into the tool.A structural issue on the hemostasis valve of the introducer was alleged.The introducer was not used and replaced to proceed with the procedure.Then, fluoroscopy imaging was performed, and air was suspected to be present in the right atrium and right ventricular outflow tract.The air was dissipated eventually, and the procedure was concluded with no further patient consequences.Patient condition was stable post operation.

• Brand Name: AVEIR¿ INTRODUCER KIT ¿ 50 CM
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25660801
• Report Number: 2017865-2026-13471
• Device Sequence Number: 16053944
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)11238385(17)281231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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 Model Number: LSN25501
• Device Lot Number: 11238385
• Was Device Available for Evaluation?: No
• 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: 06/21/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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: Unknown