MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Introducer Kit ¿ 50 cm; Introducer, Catheter

Model Number	LSN25501
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury

• 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: 50745013
• Report Number: 2017865-2026-19359
• Device Sequence Number: 10235700
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)11440039(17)290531
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSN25501
• Device Lot Number: 11440039
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown