MAUDE Adverse Event Report: ABBOTT AVEIR¿ DELIVERY CATHETER; LEADLESS PACEMAKER

Model Number	LSCD111
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while entering the right ventricle, the protective sleeve of the delivery catheter exhibited ballooning while shooting contrast.The delivery catheter and leadless pacemaker (lp) were removed.The patient then experienced low blood pressure and pericardial effusion resulting in tamponade.Pericardiocentesis was performed to resolve the event.The lp was successfully implanted with a new delivery catheter.The patient was in stable condition.
Additional Manufacturer Narrative
As received, the catheter was returned in one piece without a device attached.The reported event of ballooning of the protective sleeve was confirmed.A visual examination of the catheter revealed the protective sleeve was stretched with no damages.An x-ray examination revealed a bent sheath adjacent to the handle consistent with procedural damage.The stretched of the outer layer of the sleeve was due to pressure buildup during the attempted implant procedure.The cause of the reported event is consistent with procedural damage.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; 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: 24489962
• Report Number: 2017865-2026-04295
• Device Sequence Number: 16106358
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)10893992(17)260831
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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 Expiration Date: 08/31/2026
• Device Model Number: LSCD111
• Device Catalogue Number: LSCD111
• Device Lot Number: 10893992
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown