MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Model Number	9-ACP2-007-020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet was chosen for implant using 12f amulet delivery system.During the procedure , while implanting , it was observed that during connection between the delivery system and the amulet occluder while tightening the the rotating luer, the delivery system broke leaving a portion of its connection attached to the device's loader.No portion of the broken component was retained inside the patient or system.A new device and delivery system was chosen and the procedure was completed.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet was chosen for implant using 12f amulet delivery system.During the procedure, while implanting, it was observed that during connection between the delivery system and the amulet occluder while tightening the rotating luer, the delivery system broke leaving a portion of its connection attached to the device's loader.The breakage of the delivery system was at the screw attachment level, inside the device loader.No portion of the broken component was retained inside the patient or system.A new device and delivery system was chosen and the procedure was completed.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
It was reported that during the procedure, the delivery system was found to be fractured.Field information indicated that while implanting the device, the delivery system broke during the connection process between the delivery system and the amulet occluder.Specifically, while tightening the rotating luer, the delivery system fractured, leaving a portion of its connection attached to the device¿s loader.The break occurred at the screw attachment level, inside the device loader.The device was returned for analysis, and the fractured piece was found attached within the screw component of the loader, identified as the sheath hub.A review of the device history record confirmed that all manufacturing and inspection operations were completed appropriately and that the product met specifications prior to shipment.Additionally, a review of the complaint history revealed no similar reports associated with this lot.Based on the available information, there is no indication of a product quality issue related to the device¿s labeling, design, or manufacturing.

• Brand Name: AMPLATZER AMULET
• Common Device Name: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23833283
• Report Number: 2135147-2025-07490
• Device Sequence Number: 14722768
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)290131(10)10198842
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P200049
• 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,Followup
• Report Date (Section B): 03/13/2026

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: 9-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10198842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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