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	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet was chosen for implant using a 14f amulet delivery sheath.The flushing performed according to the instructions for use (ifu) and there was no visible damage observed on the package prior to opening.During the procedure, while doing the contrast medium injection, the three-way stopcock of the amulet device was reported to be broken.There were no multiple recaptures or manipulations of the device during the procedure and no leak was detected.The procedure was completed using a 22mm amplatzer amulet.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information provided.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a fractured three-way stopcock was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.A detailed manufacturing assessment was provided from manufacturing site, which indicates that adequate to detect issues related to this assembly.Therefore, it can be concluded that the defect observed during the procedure did not originate at the costa rica manufacturing site.Furthermore, controls exist to ensure that the three-way stopcock is complete, undamaged, and properly tightened prior to shipment.There is no evidence of a manufacturing deficiency identified during the review.The exact root cause of this issue could not be determined.However, it is possible that the cause could have occurred during handling of the device.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23967758
• Report Number: 2135147-2026-00082
• Device Sequence Number: 4746614
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300531(10)10914594
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/02/2026

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: 10914594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14F AMULET DELIVERY SHEATH
• Patient Sex: Unknown