MAUDE Adverse Event Report: Abbott Aveir¿ Delivery Catheter; Leadless Pacemaker

Model Number	LSCD111
Medical Device Problem Codes	Material Fragmentation (1261); Connection Problem (2900); Activation Failure (3270); Premature Separation (4045)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During repositioning at initial implant of a right ventricular (rv) leadless pacemaker (lp), a docking issue was observed on the delivery catheter as the protective sleeve could not advance over the rv lp due to suspected tissue interference.The delivery catheter was then unable to go into tether mode.After multiple attempts, the rv lp prematurely separated from the delivery catheter and remains fixated following the release.Following the release, it was observed that only one tether was visible on the delivery catheter.The patient was stable with no consequences.

• Brand Name: Aveir¿ Delivery Catheter
• Common Device Name: Leadless Pacemaker
• Manufacturer (Section D): Abbott; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50594673
• Report Number: 2017865-2026-18609
• Device Sequence Number: 13318249
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)11284224(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P150035
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: LSCD111
• Device Catalogue Number: LSCD111
• Device Lot Number: 11284224
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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