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

Model Number	STRBL-14F-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd_1064 - veritas, patient site id: (b)(6).It was reported that on (b)(6) 2025 a 28mm amplatzer amulet 2 was chosen for implant with a 14f amulet steerable delivery sheath.Post-procedurally, a hematoma at the vascular access site was noted and the patient's hemoglobin dropped from 15.1 to 10.1 mg/dl.The patient was admitted to the intensive care unit and a femostop was placed.The patient was discharged on (b)(6) 2025.It was also reported that on (b)(6) 2025, the patient received a blood transfusion.
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.
Additional Manufacturer Narrative
It was reported that post amulet implant procedure a hematoma at the vascular access site was noted and the patient's hemoglobin dropped.The device was not returned to abbott for analysis.Based on the information received, the cause of the reported hematoma could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The reported unexpected medical intervention and surgical intervention were the results of case-specific circumstances, as a pressure was applied and the patient also received a blood transfusion.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
(b)(4) - veritas, patient site id: (b)(6).It was reported that on (b)(6) 2025 a 28mm amplatzer amulet 2 was chosen for implant with a 14f amulet steerable delivery sheath.Post-procedurally, a hematoma at the vascular access site was noted and the patient's hemoglobin dropped from 15.1 to 10.1 mg/dl.The patient was admitted to the intensive care unit and a femostop was placed.The patient was discharged on (b)(6) 2025.It was also reported that on (b)(6) 2025, the patient received a blood transfusion.

• 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: 22609168
• Report Number: 2135147-2025-04102
• Device Sequence Number: 5384394
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)280331(10)10809528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 10809528
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 84 KG