MAUDE Adverse Event Report: ABBOTT AVEIR¿ INTRODUCER KIT ¿ 50 CM; INTRODUCER, CATHETER

Model Number	LSN25501
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a venous rupture occurred when the introducer was advanced into the patient.The introducer was removed.Dilation was performed and a new introducer was able to be advanced into the right atrium.Another venous rupture occurred while advancing the second introducer.The event was suspected to be due to due to tortuous anatomy.No intervention was required to resolve the event.The procedure was aborted and the patient was in stable condition.
Additional Manufacturer Narrative
Correction: upon review, the introducer should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
Event or Problem Description
Corrected information: additional information received indicated the reported event of venous rupture did not occur.The introducer was only damaged during the procedure.The patient is in stable condition and did not experience any adverse consequences.
Additional Manufacturer Narrative
The reported event of damaged introducer was confirmed.As received, an introducer was returned in one piece with the dilator.A visual examination revealed the introducer sheath was kinked, the distal tip was damaged, and sheathing layers were separated.The cause of the reported event was consistent with procedural damage.

• Brand Name: AVEIR¿ INTRODUCER KIT ¿ 50 CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24238430
• Report Number: 2017865-2026-02144
• Device Sequence Number: 18385133
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)11110462(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: LSN25501
• Device Lot Number: 11110462
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/02/2026; 03/20/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/26/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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: Other
• Patient Sex: Unknown