MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-007-018
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 18mm amplatzer amulet left atrial appendage occluder was chosen for a procedure using a 12f amulet delivery sheath.During the deployment amulet 18mm in the left auricle appendage a ball position in an amulet delivery sheath.After continue taking out the device lobe and disque and they see a thread in the left atrium with trans-oesophageal echocardiogram (toe).They take back the amulet and we see the thread coming out the device.They confirmed the sheath was reused.A new 18mm amplatzer amulet left atrial appendage occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 18mm amplatzer amulet left atrial appendage occluder was chosen for a procedure using a 12f amulet delivery sheath.During the deployment amulet 18mm in the left auricle appendage a ball position in a amulet delivery sheath.After continue taking out the device lobe and disque and they see a thread in the left atrium with trans-oesophageal echocardiogram (toe).They take back the amulet and we see the thread coming out the device.They confirmed the sheath was reused.A new 18mm amplatzer amulet left atrial appendage occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
An event of foreign material was reported.Upon initial inspection, the device was visually and microscopic examined and foreign material was observed on the amulet.The returned loader contained a bent damage.No other anomalies were noted.The filament was returned to abbott for investigation and is consistent with inner liner from the delivery system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported foreign material is related to user error.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 ; +1(651)756-5400
• MDR Report Key: 25491889
• Report Number: 2135147-2026-04056
• Device Sequence Number: 18751637
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)270930(10)8691232
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/24/2026

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-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 8691232
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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