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	06/16/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Clinical information: (b)(6) veritas study, patient site id: (b)(6) ,(b)(4).It was reported on (b)(6) 2025, a 34mm amplatzer amulet 2 occluder was selected for implant using a 14f amplatzer steerable delivery sheath.On (b)(6) 2025, it's noted via computed tomography scan that the patient had a spontaneous rectus sheath tear.The decision was made to hospitalize the patient overnight for observation.No additional information was provided.
Event or Problem Description
Clinical information: crd_1064 - veritas study, patient site id: (b)(6).It was reported on (b)(6) 2025, a 34mm amplatzer amulet 2 occluder was selected for implant using a 14f amplatzer steerable delivery sheath.On (b)(6) 2025, it was noted via computed tomography abdomen scan that the patient had a spontaneous rectus sheath tear secondary to heparin leading to spontaneous hematoma.The decision was made to hospitalize the patient overnight for observation.The patient was discharged on (b)(6) 2025.
Additional Manufacturer Narrative
An event of hematoma 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported hematoma could not be conclusively determined.The hospitalization appears to have been case-specific, intended for patient monitoring.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22484309
• Report Number: 2135147-2025-03806
• Device Sequence Number: 8554566
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)261024(10)10727464
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/13/2025

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: 10727464
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Patient Race: Black Or African American