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); Component Misassembled (4004)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/03/2026
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 air aspiration, and the large amount of air was absorbed into the body after entering.It was also found that the hemostasis valve on the introducer appeared to be inverted.A replacement introducer was used but the same issues were noted.As there were no serious consequences noted, the procedure was performed as planned.There were no patient consequences.
Additional Manufacturer Narrative
The reported events of fluid leak and inverted valve were not confirmed.As received, an introducer was returned in one piece.Visual examination did not find any anomalies.Leak testing was performed, and no leakage was noted.No anomalies were found.

• 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: 24973813
• Report Number: 2017865-2026-08452
• Device Sequence Number: 4979063
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)11251707(17)270131
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 11251707
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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