MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Delivery Catheter; Leadless Pacemaker

Model Number	LSCD201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure of a right atrium leadless pacemaker (ralp) that after fixating and transitioning to tether mode that there was low pacing impedance and high capture threshold.Angiography was performed and revealed that the helix of the ralp perforated the right atrial appendage.After some time, the physician elected to unscrew since the threshold was not decreasing, at this time, the patient's blood pressure dropped due to cardiac tamponade.The physician elected to abandon the implant procedure.The physician performed pericardiocentesis and the blood pressure stabilized.After about an hour the patient worsened again, and physician decided to open the chest and perform surgery to repair the wound.The patient was stable following the procedure.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: Aveir¿ Delivery Catheter
• Common Device Name: Leadless Pacemaker
• 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: 50935828
• Report Number: 2017865-2026-20623
• Device Sequence Number: 16139576
• Product Code: PNJ
• UDI-Device Identifier: 05415067038487
• UDI-Public: (01)05415067038487(10)11452990(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: LSCD201
• Device Catalogue Number: LSCD201
• Device Lot Number: 11452990
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Introducer
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown