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 Codes	Anemia (1706); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041)
Date of Event	05/21/2025
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
Crd_1064 - veritas, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 25mm amplatzer amulet 2 was chosen for implant with a 14f amulet steerable delivery sheath.A figure 8-stitch was used to close access site.Post-procedurally but prior to discharge, the patient developed anemia and a hematoma at access site.The patient's hemoglobin dropped by 5 points and became hypotensive.The patient was transfused 2 units of packed red blood cells.Patient also developed significant acute kidney injury and was put on intravenous diuresis.Patient transitioned over to lasix and their conditions improved.Patient was admitted to rehab for further therapy.
Additional Manufacturer Narrative
An event of anemia and a hematoma at access site, hypotension and significant acute kidney injury was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported patient effects could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.The reported unexpected medical intervention was results of case-specific circumstance.The patient was transfused two units of packed red blood cells.The patient was put on intravenous diuresis.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
N/a.

• 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: 22609482
• Report Number: 2135147-2025-04103
• Device Sequence Number: 13195971
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)280131(10)10731404
• 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): 09/08/2025

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: 10731404
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 151 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White