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

Model Number	STRBL-14F-075
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using a amulet¿ steerable delivery sheath.The implanter previously tried 2 non-abbott device and 2 different transeptals.The 28mm amulet was attempted and deployed twice but did not meet close criteria.The 28mm amplatzer amulet left atrial appendage occluder was fully recaptured and a 25mm amplatzer amulet left atrial appendage occluder was deployed 3 times but was unsuccessful.Both device and sheath were fully removed from the body.A membranous piece of tissue noted on the septum upon evaluating with device and sheath outside of the body, atrial endothelium was noted on device and sheath.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using a amulet¿ steerable delivery sheath.The implanter previously tried 2 non-abbott device and 2 different transeptals.The 28mm amulet was attempted and deployed twice but did not meet close criteria.The 28mm amplatzer amulet left atrial appendage occluder was fully recaptured and a 25mm amplatzer amulet left atrial appendage occluder was deployed 3 times but was unsuccessful.Both device and sheath were fully removed from the body.A membranous piece of tissue noted on the septum upon evaluating with device and sheath outside of the body, atrial endothelium was noted on device and sheath.The patient was reported stable.
Additional Manufacturer Narrative
An event of a positioning problem and unspecific tissue damage was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported positioning problem could not be determined.The reported unspecific tissue damage is likely a cascading effect from the event, however this cannot be determined.A serious injury/illness/impairment was a result of case specific circumstances, as the intervention to treat the issue is unknown.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: medical device problem code: 2993.

• 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: 23818431
• Report Number: 2135147-2025-07411
• Device Sequence Number: 9974423
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)280229(10)10773905
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: STRBL-14F-075
• Device Catalogue Number: STRBL-14F-075
• Device Lot Number: 10773905
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Unknown