MAUDE Adverse Event Report: ABBOTT MEDICAL AMULET STEERABLE DELIVERY SHEATH; CATHETER DELIVERY SHEATH

Model Number	STRBL-14F-075
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using an amulet¿ steerable delivery sheath.During device deployment, physician noticed air in the device loader traveling toward the touhy away from the patient.The physician confirmed with transesophageal echocardiogram (tee) imager that no air was seen.The patient was not impacted and the procedure was completed successfully.The patient was reported discharged.
Additional Manufacturer Narrative
An event of air/gas noted in the delivery system during procedure was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined; however, the operational difficulties may have contributed to the reported event of air/gas in the delivery system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a amulet¿ steerable delivery sheath.During device deployment, physician noticed air in the device loader traveling toward the touhy away from the patient.The physician confirmed with transesophageal echocardiogram (tee) imager that no air was seen.The patient was not impacted and the procedure was completed successfully.The patient was reported discharged.

• Brand Name: AMULET STEERABLE DELIVERY SHEATH
• Common Device Name: CATHETER DELIVERY SHEATH
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24332244
• Report Number: 2135147-2026-00864
• Device Sequence Number: 11965186
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)280229(10)10795764
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K250426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: STRBL-14F-075
• Device Catalogue Number: STRBL-14F-075
• Device Lot Number: 10795764
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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
• Patient Age: 89 YR
• Patient Sex: Female